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TEST RÁPIDO DE ANTÍGENOS 25 ud.
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TEST RÁPIDO DE ANTÍGENOS 25 ud.
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Declaration of Conformity

                    ACON Laboratories, Incorporated
                       5850 Oberlin Drive, #340
                      San Diego, CA 92121, USA
  We, the manufacturer, declare under our sole responsibility that
                  the in vitro diagnostic device:

            Flowflex® SARS-CoV-2 Antigen Rapid Test (L031-11815)

                     classified as Others in the directive 98/79/EC,

    meets all the provisions of the directive 98/79/EC on in vitro diagnostic
                       medical devices which apply to it

                     The self-declaration is according to Annex III
                        (excluding Section 6) of the Directive.

                                  Authorized Representative:
                              Medical Device Safety Service GmbH
                                        Schiffgraben 41
                                  30175 Hannover, Germany

Signed this 13 day of October, 2020
in San Diego, CA, USA

                                                           Qiyi Xie, MD, MPH
                                            Senior Staff, Regulatory Affairs & Clinical Affairs
                                                         Acon Laboratories, Inc.

     5850 Oberlin Drive, #340 · San Diego, CA 92121, USA · Tel: (858) 875-8000 · Fax: (858) 875-8099
                                        E-mail: info@aconlabs.com
FlowflexTM SARS-CoV-2 Antigen Rapid Test
           Evaluation Report

            November 2020
Flowflex SARS-CoV-2 Antigen Rapid Test Evaluation Report

The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the
qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens
directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven
days of the onset of symptoms. The Flowflex SARS-CoV-2 Antigen Rapid Test does not differentiate
between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable
in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of
viral antigens, but clinical correlation with patient history and other diagnostic information is necessary
to determine infection status. Positive results do not rule out bacterial infection or co-infection with other
viruses. The agent detected may not be the definite cause of disease.
Negative results from patients with more than seven days post symptom onset should be treated as
presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative
results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or
patient management decisions, including infection control decisions. Negative results should be
considered in the context of a patient s recent exposures, history and the presence of clinical signs and
symptoms consistent with COVID-19.

The Flowflex SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel
and individuals trained in point of care settings.

     1. Purpose: To evaluate the performance of the Flowflex SARS-CoV-2 Antigen Rapid Test

     2. Material:

                       Materials                                          Lot
           SARS-CoV-2 Antigen Rapid Test       202009101            202009001             202009201
           Extraction Buffer                   202008001            202008002             202008003

     3. Study procedure and results
        3.1 Imprecision/reproducibility Study
            Material:
               SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
               Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
               SARS-CoV-2 Antigen Negative Sample          Lot#: COVAG200904N
               SARS-CoV-2 Antigen Low Positive Sample P3      Lot#: COVAG200904P3
               SARS-CoV-2 Antigen Middle Positive Sample P2 Lot#: COVAG200904P2
               SARS-CoV-2 Antigen High Positive Sample P1      Lot#: COVAG200904P1

                                                      2
Procedure:
         3 Lots of SARS-CoV-2 Antigen Rapid Test were tested according to the package insert by
         3 operators. Each operator performed 2 tests on each control for 5 days in 2 sites in China.
         Total 180 tests were performed per each control: 2 replicates X 5 days X 3 lots X 3
         operators X 2 sites = 180 tests.
    Test results:
      SARS-CoV-2                      Lot 1                 Lot 2                    Lot 3
      Samples
     High Pos                   + / 60 replicates     + / 60 replicates        + / 60 replicates
     Mid Pos                    + / 60 replicates     + / 60 replicates        + / 60 replicates
     Low Pos                    + / 60 replicates     + / 60 replicates        + / 60 replicates
     Neg                        - / 60 replicates     - / 60 replicates        - / 60 replicates
    Conclusions:
    All three lots identified the samples 100% correctly as negative or positive.

3.2 Limit of Detection (LOD)
    Material:
        SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
        Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
        SARS-CoV-2 viral culture
    Procedure:
    1. Sample Application Method: Apply 4~5 drops (approximately 100~125 ul) of sample to
        the sample well on the test cassette, then start the timer, read the result at 15-20 minutes.
    2. Dilute the high concentration SARS-CoV-2 viral culture with the Extraction Buffer.
    3. Use 3 lots of SARS-CoV-2 antigen rapid test to test the samples, and every sample is tested
        in 10 replicates. Calculate the detectable rate for each sample.
    4. The minimum concentration with                detectable rate is defined as the minimum
        detectability (LOD).
    Test results:
    Culture sample:
                                                                      Detectable
         Concentration       Lot              Test Result
                                                                          rate
                            Lot 1          + / 10 replicates
           2.56 x 103                                                    100%
                            Lot 2          + / 10 replicates
           TCID50/mL                                                    (30/30)
                            Lot 3          + / 10 replicates

                            Lot 1          + / 10 replicates
                     3
           1.28 x 10                                                     100%
                            Lot 2          + / 10 replicates
           TCID50/mL                                                    (30/30)
                            Lot 3          + / 10 replicates

                                             3
Lot 1          + / 10 replicates
                   2
           6.4 x 10                                                   100%
                          Lot 2          + / 10 replicates
          TCID50/mL                                                  (30/30)
                          Lot 3          + / 10 replicates

                          Lot 1          + / 10 replicates
                   2
           3.2 x 10                                                   100%
                          Lot 2          + / 10 replicates
          TCID50/mL                                                  (30/30)
                          Lot 3          + / 10 replicates

                          Lot 1          + / 10 replicates
           1.6 x 102                                                  96.7%
                          Lot 2          + / 10 replicates
          TCID50/mL                                                  (29/30)
                          Lot 3    + 9 replicates / - 1 replicate

                          Lot 1          - / 10 replicates
            8 x 10
                          Lot 2          - / 10 replicates          0% (0/30)
          TCID50/mL
                          Lot 3          - / 10 replicates

   Conclusion:
   According to the test result, the LOD is 1.6 x 102 TCID50/mL

3.3 Clinical study – nasal swabs
    A multi-site clinical study was conducted to evaluate the performance of the SARS-CoV-2
    Antigen Rapid Test, and the results are shown below.

   Site 1 Material:
       SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
       Comparison method: RT-PCR, Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit
       (PCR-Fluorescence Probing), manufactured by Sansure BioTech Inc.
       Extraction Buffer, Lot1#:202008001
       Nasal swab samples from infected patients and non-infected patients
   Site 1 Procedure:
   1. Study was conducted in Hangzhou, China
               304 clinical nasal swabs were collected from patients who were suspected of
               COVID-19 (within 7 days of onset). All the samples were confirmed with RT-PCR.
               34 positive clinical nasal swabs collected from patients. 29 samples with Ct counts
2. Following product package insert, performed the test and read the result at 15-20
               minutes.

            Test results:
           Candidate method                                      RT-PCR method
                                         Negative Positive*                        Total
Flowflex             Negative              269        1                             270
  Test               Positive               1        33                             34
 Results              Total                270       34                             304

            Site 2 Material:
                SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
                Comparison method: TaqPath COVID-19 Combo Kit, FDA authorized RT-PCR test for
                emergency use, manufactured by Thermo Fisher Scientific, Inc.

                Nasal swab samples from infected patients and non-infected patients

            Site 2 Procedure:
            1. Study is being conducted in multiple U.S. sites in California and Florida, and it is ongoing.
                So far, 125 clinical nasal swabs were collected from patients who were suspected of
                COVID-19 (within 7 days of onset). All the samples were confirmed with RT-PCR method.
            2. Following product package insert, performed the test and read the result at 15-20
                minutes.

            Test results:

           Candidate method                                       RT-PCR method
                                       Negative Positive                          Total
Flowflex           Negative               32         3*                            35
  Test              Positive              1          89                            90
 Results             Total                33         92                            125
            *3 samples with PCR CT value 33.97 – 33.99

          Summary of combined clinical studies at all sites:
         Candidate method                                    RT-PCR method
                                    Negative Positive                      Total
Flowflex          Negative             301          4                       305
  Test             Positive             2         122                       124
 Results            Total              303        126                       429

                                                     5
Conclusions:
    The sensitivity, specificity, and accuracy are meeting MHRA acceptable requirement, which
    has sensitivity greater than 80% and specificity greater than 95%.
                                          Performance 95% CI
                             Sensitivity      96.8%      92.1%-
                                            (122/126)     99.1%
                             Specificity      99.3%      97.6%-
                                            (301/303)     99.9%
                              Accuracy        98.6%      97.0%
                                            (423/429)    -99.5%

3.4 Endogenous Interfering Substances
    To determine if the substances that naturally present in respiratory specimens or that may
    be artificially introduced into the nasal cavity interfere with Flowflex SARS-CoV-2 Antigen
    Test.

    Material:
       SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
       Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
       Lot#324615
       Extraction Buffer, Lot# 102820
       Pooled human negative clinical matrix

    Procedure 1: Test the endogenous substances in the absence of heat inactivated SARS-Cov-
    2 virus.
    The samples were prepared by spiking each substance into the human negative clinical
    matrix to the target concentration listed in the table below. Each sample was tested in
    triplicate with Flowflex SARS-CoV-2 Antigen Test according to the package insert.

    Test Results:
    No cross-reactivity was observed with the endogenous interfering substances when tested
    at the concentration presented in the table below.

    Procedure 2: Test the endogenous substances in the presence of heat inactivated SARS-CoV-
    2 virus.
    The samples were prepared by spiking each substance and heat inactivated SARS-Cov-2
    virus into the human negative clinical matrix to the target concentration in the presence of
    heat inactivated SARS-CoV-2 virus at 9.71 x 102 TCID50/mL. Each sample was tested in
    triplicate according to the package insert.

    Test Results:

                                           6
No interference was observed.

  Endogenous Interference Substances Study Results

                                                                               Cross-
                                                                                          Interference
          Interfering Substances         Active Ingredient   Concentration    Reactive
                                                                                             Results
                                                                               Results

                                                Mucin           0.5% w/v      -   -   -   +    +    +
Endogenous
                                             Whole Blood         4% v/v       -   -   -   +    +    +
Afrin Original Nasal Spray                   Oxymetazoline      15% v/v       -   -   -   +    +    +

ALKALOL Allergy Relief Nasal Spray           Homeopathic      1:10 Dilution   -   -   -   +    +    +

                                               Menthol,
Chloraseptic Max Sore Throat Lozenges                          1.5 mg/mL      -   -   -   +    +    +
                                              Benzocaine
CVS Health Fluticasone Propionate             Fluticasone
                                                                 5% v/v       -   -   -   +    +    +
Nasal Spray                                   propionate

Equate Fast-Acting Nasal Spray               Phenylephrine      15% v/v       -   -   -   +    +    +

Equate Sore Throat Phenol Oral
                                                Phenol          15% v/v       -   -   -   +    +    +
Anesthetic Spray
Original Extra Strong Menthol Cough
                                               Menthol         1.5 mg/mL      -   -   -   +    +    +
Lozenges
NasalCrom Nasal Spray                          Cromolyn         15% v/v       -   -   -   +    +    +
NeilMed NasoGel for Dry Noses           Sodium Hyaluronate       5% v/v       -   -   -   +    +    +
                                             Dyclonine
Throat Lozenge                                                 1.5mg/mL       -   -   -   +    +    +
                                           Hydrochloride

                                         Galphimia glauca,
Zicam Cold Remedy                        Luffa operculata,       5% v/v       -   -   -   +    +    +
                                             Sabadilla

Antibiotic                                     Mupirocin        10 mg/mL      -   -   -   +    +    +
                                              Oseltamivir
Tamiflu                                                         5 mg/mL       -   -   -   +    +    +
                                              Phosphate
Antibiotic                                    Tobramycin        4 ug/mL       -   -   -   +    +    +

             Conclusion:
             Based on the data generated by this study, the endogenous interfering substances tested do
             not cross-react or interfere with Flowflex SARS-CoV-2 Antigen test.

                                                     7
3.5 Cross Reactivity (Analytical Specificity)
    To demonstrate the related pathogens and organisms that are reasonably likely to be
    present in the nasal cavity do not interfere with test performance of Flowflex SARS-Cov-2
    Antigen Test.

    Material:
       SARS-CoV-2 Antigen Rapid Test, Lot#2:202009001
       Extraction Buffer, Lot#102820
       Pooled human negative clinical matrix

    Procedure: Cross-Reactivity Wet Testing
    Samples were prepared by spiking each stock inactivated viruses and bacteria into the pooled
    human negative clinical matrix. Each organism and virus were tested in triplicate with Flowflex
    SARS-CoV-2 Antigen Test.

    Test Results:
    No cross-reactivity was observed with the following bacteria and viruses when tested at the
    concentration presented in the table below.

                                                      Test         Cross-Reactive
                Potential Cross -Reactant
                                                  Concentration       Results

                                                    1.14 x 106
                  Adenovirus                                         -     -     -
                                                    TCID50/mL
                                                    9.50 x 105
                  Enterovirus                                        -     -     -
                                                    TCID50/mL
                                                    1.04 x 105
                  Human coronavirus 229E                             -     -     -
                                                    TCID50/mL

                                                    2.63 x 105
                  Human coronavirus OC43                             -     -     -
        Virus                                       TCID50/mL

                                                     1.0 x 105
                  Human coronavirus NL63                             -     -     -
                                                    TCID50/mL

                                                    1.25 x 105
                  Human Metapneumovirus                              -     -     -
                                                    TCID50/mL
                                                    7.90 x 105
                  MERS-coronavirus                                   -     -     -
                                                    TCID50/mL

                                            8
1.04 x 105
           Influenza A                                       -   -   -
                                             TCID50/mL
                                             1.04 x 105
           Influenza B                                       -   -   -
                                             TCID50/mL
                                             1.25 x 105
           Parainfluenza virus 1                             -   -   -
                                             TCID50/mL
                                             3.78 x 105
           Parainfluenza virus 2                             -   -   -
                                             TCID50/mL
                                              1.0 x 105
           Parainfluenza virus 3                             -   -   -
                                             TCID50/mL
                                             2.88 x 106
           Parainfluenza virus 4                             -   -   -
                                             TCID50/mL
                                             3.15 x 105
           Respiratory syncytial virus                       -   -   -
                                             TCID50/mL
                                             3.15 x 105
           Rhinovirus                                        -   -   -
                                             TCID50/mL
                                             2.83 x 109
           Bordetella pertussis                              -   -   -
                                              CFU/mL
                                             3.13 x 108
           Chlamydia trachomatis                             -   -   -
                                              CFU/mL
                                             1.36 x 108
           Haemophilus influenza                             -   -   -
                                              CFU/mL
                                             4.08 x 109
           Legionella pneumophila                            -   -   -
                                              CFU/mL
                                             1.72 x 107
           Mycobacterium tuberculosis                        -   -   -
                                              CFU/mL
                                             7.90 x 107
           Mycoplasma pneumoniae                             -   -   -
Bacteria                                      CFU/mL
                                             2.32 x 109
           Staphylococcus epidermidis                        -   -   -
                                              CFU/mL
                                             1.04 x 108
           Streptococcus pneumoniae                          -   -   -
                                              CFU/mL
                                             4.10 x 106
           Streptococcus pyogenes                            -   -   -
                                              CFU/mL
           Pneumocystis jirovecii-S.         8.63 x 107
                                                             -   -   -
           cerevisiae                         CFU/mL
                                             1.87 x 108
           Pseudomonas aeruginosa                            -   -   -
                                              CFU/mL
           Pooled human nasal wash              N/A          -   -   -
                                                         8
                                             1.57 x 10
 Yeast     Candida albicans                                  -   -   -
                                              CFU/mL

                                         9
3.6 Microbial Interference Studies
    To demonstrate that false negatives will not occur with Flowflex SARS-Cov-2 Antigen Test
    when SARS-CoV-2 is present in a specimen with other microorganisms.

   Material:
      SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
      Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
      Lot#324615
      Extraction Buffer, Lot#102820
      Pooled human negative clinical matrix

   Procedure:
   The samples were prepared by spiking each inactivated viruses and bacterial cells and heat
   inactivated SARS-CoV-2 virus into the pooled human negative clinical matrix. Each organism
   and virus in the presence of heat inactivated SARS-CoV-2 virus at 9.71 x 102 TCID50/mL were
   tested in triplicate with Flowflex SARS-CoV-2 Antigen Test.

   Test Results:
   No interference was observed in the presence of heat inactivated SARS-CoV-2 virus with the
   following bacteria and viruses when tested at the concentration presented in the table below.

                                                       Test        Interference
                  Potential Cross -Reactant
                                                   Concentration      Results

                                                    1.14 x 106
                   Adenovirus                                      +    +    +
                                                    TCID50/mL
                                                    9.50 x 105
                   Enterovirus                                     +    +    +
                                                    TCID50/mL
                                                    1.04 x 105
                   Human coronavirus 229E                          +    +    +
                                                    TCID50/mL

                                                    2.63 x 105
                   Human coronavirus OC43                          +    +    +
          Virus                                     TCID50/mL

                                                     1.0 x 105
                   Human coronavirus NL63                          +    +    +
                                                    TCID50/mL

                                                    1.25 x 105
                   Human Metapneumovirus                           +    +    +
                                                    TCID50/mL
                                                    7.90 x 105
                   MERS-coronavirus                                +    +    +
                                                    TCID50/mL

                                              10
1.04 x 105
                Influenza A                                   +   +   +
                                                 TCID50/mL
                                                 1.04 x 105
                Influenza B                                   +   +   +
                                                 TCID50/mL
                                                 1.25 x 105
                Parainfluenza virus 1                         +   +   +
                                                 TCID50/mL
                                                 3.78 x 105
                Parainfluenza virus 2                         +   +   +
                                                 TCID50/mL
                                                  1.0 x 105
                Parainfluenza virus 3                         +   +   +
                                                 TCID50/mL
                                                 2.88 x 106
                Parainfluenza virus 4                         +   +   +
                                                 TCID50/mL
                                                 3.15 x 105
                Respiratory syncytial virus                   +   +   +
                                                 TCID50/mL
                                                 3.15 x 105
                Rhinovirus                                    +   +   +
                                                 TCID50/mL
                                                 2.83 x 109
                Bordetella pertussis                          +   +   +
                                                  CFU/mL
                                                 3.13 x 108
                Chlamydia trachomatis                         +   +   +
                                                  CFU/mL
                                                 1.36 x 108
                Haemophilus influenza                         +   +   +
                                                  CFU/mL
                                                 4.08 x 109
                Legionella pneumophila                        +   +   +
                                                  CFU/mL
                                                 1.72 x 107
                Mycobacterium tuberculosis                    +   +   +
                                                  CFU/mL
                                                 7.90 x 107
                Mycoplasma pneumoniae                         +   +   +
     Bacteria                                     CFU/mL
                                                 2.32 x 109
                Staphylococcus epidermidis                    +   +   +
                                                  CFU/mL
                                                 1.04 x 108
                Streptococcus pneumoniae                      +   +   +
                                                  CFU/mL
                                                 4.10 x 106
                Streptococcus pyogenes                        +   +   +
                                                  CFU/mL
                Pneumocystis jirovecii-S.        8.63 x 107
                                                              +   +   +
                cerevisiae                        CFU/mL
                                                 1.87 x 108
                Pseudomonas aeruginosa                        +   +   +
                                                  CFU/mL
                Pooled human nasal wash             N/A       +   +   +
                                                          8
                                                 1.57 x 10
     Yeast      Candida albicans                              +   +   +
                                                  CFU/mL

Conclusion:

                                            11
Based on the data generated by this study, the organisms or viruses tested do not cross-react
    or interfere with Flowflex SARS-CoV-2 Antigen test.

3.7 Hook effect
    To evaluate if the false negative result can be observed when test very high levels of heat
    inactivated SARS-CoV-2 virus with Flowflex SARS-Cov-2 Antigen Test.

    Material:
       SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
       Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
       Lot#324615
       Extraction Buffer, Lot#102820
       Pooled human negative clinical matrix

    Procedure:
    Samples were prepared by adding heat inactivated SARS CoV-2 virus into the human negative
    nasal matrix pool for preparing the highest concentration 7.5 x 105 TCID50/mL of heat
    inactivated SARS-CoV-2 available in the human negative nasal matrix. Contrived nasal swab
    samples were prepared by absorbing 50 uL of the virus at 7.5 x 105 TCID50/mL onto the swab.
    The contrived swab samples were tested in triplicate according to the package insert.

    Conclusion:
    No high dose hook effect was observed when tested with up to a concentration of 7.5 x 105
    TCID50/mL of heat inactivated SARS CoV virus with Flowflex SARS CoV Antigen Test.

3.8 Read Time Flex
    To demonstrate that the test result is stable when read within the recommended time
    window.

    Material:
    SARS-CoV-2 Antigen Rapid Test, Lot#1:COV0110005
    Buffer, Lot#:TDE20110009
    SARS-CoV-2 Antigen Negative Sample        Lot#: 20201104
    SARS-CoV-2 Antigen Low Positive Control   Lot#: COVAG200930L
    SARS-CoV-2 Antigen Middle Positive Control Lot#: COVAG200930M
    ACON Rapid Flow Test Color Card, Lot#20200112

    Procedure:
    SARS-CoV-2 Antigen negative, high, middle and low positive sample are tested with SARS-
    CoV-2 Antigen Rapid Test according to package insert. Each test was performed in triplicate.
    The test results were recorded at 5, 10, 15, 20 and 30 mins.

                                           12
Test results:
    SARS-CoV-          5 min          10 min          15 min           20 min          30 min
    2 Samples
    Neg                 -/3             -/3             -/3             -/3             -/3
                     replicates      replicates      replicates      replicates      replicates
     Low Pos            -/3             +/ 3           +/3             +/3             +/3
                     replicates      replicates      replicates      replicates      replicates
     Mid Pos           +/3             +/3             +/3             +/3             +/3
                     replicates      replicates      replicates      replicates      replicates
     High Pos          +/3             +/3             +/3             +/3             +/3
                     replicates      replicates      replicates      replicates      replicates

   Conclusion:
   The results are stable when read between 10 minutes to 30 minutes.

3.9 Stability Study
    Material:
        SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
        Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
        SARS-CoV-2 Antigen Negative Sample          Lot#: COVAG200904N
        SARS-CoV-2 Antigen Low Positive Sample P3      Lot#: COVAG200904P3
        SARS-CoV-2 Antigen Middle Positive Sample P2 Lot#: COVAG200904P2
        SARS-CoV-2 Antigen High Positive Sample P1      Lot#: COVAG200904P1
        SARS-CoV-2 Antigen positive control swab, Lot#1: 202009003P-1, Lot#2: 202009003P-2,
        Lot#3: 202009003P-3
        SARS-CoV-2 Antigen negative control swab, Lot#1: 202009003N-1, Lot#2: 202009003N-
        2, Lot#3: 202009003N-3

   3.9.1 Accelerated stability
   Estimate the shelf life for SARS-CoV-2 Antigen Rapid Test, Extraction Buffer and Control
   Swabs basing on the accelerate stability study.

   Procedure:
   Accelerated stability study for three lots (including tests in individual pouches, control swabs
   in individual pouches, extraction buffer in tube) will be stored at 55°C/65°C to estimate
   product stability. Tests will be assayed according to package insert at designated time points.
   For each device lot, run 3 replicates per sample at each time points. Read the results according
   to package insert.

                                           13
Test results:
                          Result of SARS-CoV-2 Antigen Rapid Test
55°C
 SARS-CoV-2 Samples                  0 day             7 days             14 days
 Neg                            - / 3 tests x 3    - / 3 tests x 3    - / 3 tests x 3
                                      lots               lots               lots
 Low Pos                        + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots
 Mid Pos                        + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots
 High Pos                       + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots

65°C
 SARS-CoV-2 Samples                  0 day             7 days             14 days
 Neg                            - / 3 tests x 3    - / 3 tests x 3    - / 3 tests x 3
                                      lots               lots               lots
 Low Pos                        + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots
 Mid Pos                        + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots
 High Pos                       + / 3 tests x 3    + / 3 tests x 3    + / 3 tests x 3
                                      lots               lots               lots

                         Result of SARS-CoV-2 Antigen Control swab:
55°C
 Samples                             0 day            7 days              14 days
 Positive Control Swab          + / 3 tests x 3   + / 3 tests x 3     + / 3 tests x 3
                                      lots              lots                lots
 Negative Control Swab          - / 3 tests x 3   - / 3 tests x 3     - / 3 tests x 3
                                      lots              lots                lots

65°C
 Samples                             0 day            7 days              14 days
 Positive Control Swab          + / 3 tests x 3   + / 3 tests x 3     + / 3 tests x 3
                                      lots              lots                lots
 Negative Control Swab          - / 3 tests x 3   - / 3 tests x 3     - / 3 tests x 3
                                      lots              lots                lots

Conclusion:

                                       14
SARS-CoV-2 Antigen Rapid Test, extraction buffer and SARS-CoV-2 Antigen Control Swabs are
 stable at 65°C for 14 days, so the shelf life can be estimated at least 24 months.

 3.9.2 Real time stability
 Estimate the shelf life for SARS-CoV-2 Antigen Rapid Test, Extraction Buffer and Control
 Swabs basing on the real time stability study.

 Procedure:
 Real time stability study for three lots (including tests in individual pouches, control swabs in
 individual pouches, extraction buffer in tube) will be stored at 2-8°C/30°C to estimate product
 stability. Tests will be assayed according to package insert at designated time points every 3
 months until the timepoints that performance does not meet the acceptance criteria. For
 each device lot, negative and different levels of positive samples will be tested, run 3
 replicates per sample at each time points. Read the results according to package insert.

 Acceptance criteria:
 Negative sample will generate negative result
 Low positive, medium positive and high positive sample will generate positive results

 Test results:
                                Result of SARS-CoV-2 Antigen Rapid Test:
 2-8°C
SARS-CoV-
                         Neg                    Low Pos                  Mid Pos                 High Pos
2 Samples

  0 day           - / 3 tests x 3 lots     + / 3 tests x 3 lots     + / 3 tests x 3 lots    + / 3 tests x 3 lots

3 months
6 months
9 months
12 months

 30°C
SARS-CoV-
                        Neg                   Low Pos                  Mid Pos                 High Pos
2 Samples

  0 day          - / 3 tests x 3 lots    + / 3 tests x 3 lots     + / 3 tests x 3 lots     + / 3 tests x 3 lots

3 months

                                               15
6 months
9 months
12 months

                         Result of SARS-CoV-2 Antigen Control swab:
 2-8°C

SARS-CoV-2
                     Neg control swab                 Pos control swab
 Samples

   0 day             - / 3 tests x 3 lots             + / 3 tests x 3 lots

 3 months
 6 months
 9 months
 12 months

 30°C
SARS-CoV-2
                    Neg control swab                 Pos control swab
 Samples

   0 day             - / 3 tests x 3 lots            + / 3 tests x 3 lots

 3 months
 6 months
 9 months
 12 months

 Conclusion:
 The real time stability of SARS-CoV-2 Antigen Rapid Test, extraction buffer and SARS-CoV-2
 Antigen Control Swab are still in process. It is scheduled to finish in December 2022.

                                                                                   MDSS GmbH
                                                                                  Schiffgraben 41
                                                                             30175 Hannover, Germany

                                            16
Test rápido de antígenos para el                                                            REACTIVOS                                                  3. Con el mismo hisopo, repi a es e proceso en el o ro orificio
                                                                                                El case e de la pr eba con iene par c las impregnadas con an ic erpos fren e al SARS-              nasal para aseg rarse de e raer na can idad adec ada
                                                   SARS-CoV-2                                   CoV-2 sobre la membrana. El hisopo de con rol posi i o con iene an genos                           de m es ra de ambas ca idades nasales.
                                                    Prospecto                                   recombinan es del SARS-CoV-2 pre iamen e impregnados en el hisopo.
                                                                                                                                    PRECAUCIONES
                                                REF L031-11815          Espa ol
                                                                                                  Solo para so profesional de diagn s ico in i ro. No sar ras la fecha de cad cidad.
Un test rápido para realizar una detecci n cualitativa de ant genos de la nucleocápside           No comer, beber ni f mar en la ona en la q e se manip len las m es ras los ki s.
del SARS-CoV-2 en muestras obtenidas mediante hisopos nasales.                                                                                                                                  4. Re ire el hisopo de la ca idad nasal. La m es ra a es     lis a para s preparaci n
                                                                                                  No sar el es si la bolsa es da ada.                                                              con los   bos del amp n de e racci n.
Solo para uso profesional de diagn stico in vitro.                                                Manip lar las m es ras como si con ieran agen es infecciosos. Seg ir las
                                                                                                  preca ciones en igor con ra los riesgos biol gicos median e la reali aci n de                                             INSTRUCCIONES DE USO
                                      USO PREVISTO
                                                                                                  pr ebas      c mplir los procedimien os es ndar para desechar las m es ras de               Deje que la prueba y el tamp n de extracci n alcancen la temperatura ambiente
El es r pido de an genos para el SARS-CoV-2 es n inm noan lisis croma ogr fico de                 manera adec ada.
fl jo la eral des inado a la de ecci n c ali a i a del an geno de la pro e na n cleoc pside                                                                                                   (15-30 C) antes de proceder con la prueba.
                                                                                                  Usar ropa de pro ecci n como ba as de labora orio, g an es desechables gafas                1. Use n bo del amp n de e racci n para cada m es ra q e deba some erse a
del SARS-CoV-2 en m es ras ob enidas median e hisopos nasales direc amen e de
                                                                                                  pro ec oras al some er las m es ras a pr eba.                                                   pr eba e iq e e cada bo de manera adec ada.
personas c o pro eedor de asis encia sani aria sospeche q e p eden s frir COVID-19
                                                                                                  Las pr ebas ili adas deben desecharse de ac erdo con las norma i as locales. Las
d ran e los primeros sie e d as de la aparici n de s n omas. El es r pido de an genos                                                                                                         2. Desenrosque la tapa del gotero del tubo de la disolución amortiguadora de
                                                                                                  pr ebas       ili adas deben considerarse po encialmen e infecciosas               deben
para el SARS-CoV-2 no diferencia en re el SARS-CoV el SARS-CoV-2.                                                                                                                                 extracción sin apretar.
                                                                                                  desecharse de ac erdo con las norma i as locales.
Los res l ados ienen el obje i o de iden ificar el an geno de la n cleoc pside del SARS-                                                                                                      3. In rod ca el hisopo en el bo rem              alo d ran e al menos 30 seg ndos. A
                                                                                                  La h medad la empera ra p eden infl ir de forma nega i a en los res l ados.
CoV-2. Es e an geno generalmen e p ede de ec arse en las m es ras ob enidas de las                                                                                                                con in aci n, g relo al menos cinco eces mien ras ejerce presi n en los la erales
                                                                                                  Es e prospec o debe leerse por comple o an es de reali ar la pr eba. Si no se sig en
  as respira orias s periores d ran e la fase ag da de la infecci n. Un res l ado posi i o                                                                                                        del bo. Tenga c idado de no er er el con enido del bo.
                                                                                                  las ins r cciones del prospec o, podr an prod cirse res l ados imprecisos en las pr ebas.
indica la presencia de an genos ricos, pero es necesario reali ar na correlaci n cl nica                                                                                                      4. Saq e el hisopo mien ras presiona los la erales del bo para e raerle el l q ido.
con el his orial del pacien e o ros da os diagn s icos para de erminar el es ado de                                   ALMACENAMIENTO Y ESTABILIDAD
infecci n. Un res l ado posi i o no descar a las infecciones bac erianas ni las coinfecciones                                                                                                 5. Enrosq e firmemen e la apa del go ero en el bo de amp n de e racci n q e con iene
                                                                                                  El ki p ede almacenarse a empera ras de en re 2 30 C.
con o ros ir s. El ir s de ec ado podr a no ser la ca sa final de la enfermedad.                                                                                                                  la m es ra. Me cle bien la m es ra remo iendo o agi ando la par e inferior del bo.
                                                                                                  La pr eba man iene s es abilidad has a la fecha de cad cidad q e fig ra en la bolsa
Un res l ado nega i o en pacien es con s n omas ransc rridos sie e d as deber a ra arse           sellada.                                                                                    6. Saq e el case e de la pr eba de la bolsa de al minio         selo lo an es posible. Los
como indicio confirmarse con n an lisis molec lar, si f era necesario, para poder ra ar           La pr eba debe conser arse en la bolsa sellada has a s so.                                      mejores res l ados se ob endr n si el an lisis se lle a a cabo lo an es posible ras la
al pacien e. Un res l ado nega i o no descar a el con agio del SARS-CoV-2 no debe                 NO CONGELAR.                                                                                    e racci n de la m es ra en un plazo máximo de una hora desde dicha e racci n.
emplearse como base nica para las decisiones rela i as al ra amien o o la ges i n de              No sar ras la fecha de cad cidad.                                                           7. Coloq e el case e de la pr eba sobre na s perficie plana limpia.
los pacien es, incl idas las decisiones rela i as al con rol de la infecci n. Los res l ados                                                                                                  8. Vier a la m es ra en el pocillo del case e de la pr eba
nega i os deben en enderse en el con e o de las e posiciones recien es del pacien e,                                                 MATERIALES
                                                                                                                                                                                                  a. Desenrosq e la peq e a apa de la p n a del go ero.
s his orial la presencia de signos s n omas correspondien es a la COVID-19.                                                   Materiales suministrados                                            b. In ier a el bo del amp n de e racci n con el ap n de go eo hacia abajo
El es r pido de an genos para el SARS-CoV-2 deben sarlo profesionales de                          Case es de pr eba                           T bos del amp n de e racci n                            s j elo en er ical (a apro imadamen e nos 2,5 cm del pocillo de la m es ra).
labora orios cl nicos formados personas formadas en ins alaciones de a enci n m dica.             Hisopo de con rol posi i o                  Hisopo de con rol nega i o                          c. Aprie e el bo con s a idad ier a 4 go as de la m es ra procesada en el pocillo
                                       RESUMEN                                                    Hisopos nasales es riles*                   Prospec o                                               de la m es ra.
Los n e os corona ir s per enecen al g nero .1 La COVID-19 es na enfermedad                     * Los hisopos nasales est riles los produce otro fabricante.                                  9. Espere a q e apare ca(n) la(s) l nea(s) de color. El res l ado deber           erse en
respira oria infecciosa    ag da. Todas las personas presen an na predisposici n                                    Materiales necesarios y no suministrados                                      15 - 30 min os. No lea al resultado una vez transcurridos 30 minutos.
general hacia ella. Ac almen e, los pacien es con agiados con el n e o corona ir s
                                                                                                  Eq ipo de pro ecci n personal            Tempori ador
represen an la principal f en e de infecci n; las personas con agiadas asin om icas
 ambi n p eden ser na f en e de infecci n. De ac erdo con las in es igaciones                                     EXTRACCI N DE MUESTRAS Y PREPARACI N
epidemiol gicas ac ales, el periodo de inc baci n d ra en re 1 14 d as; generalmen e              El es r pido de an genos para el SARS-CoV-2 p ede reali arse sando m es ras
en re 3 7 d as. Los principales s n omas son la fiebre, el cansancio la os seca.                  ob enidas median e hisopos nasales.
Tambi n p ede obser arse en alg nos casos conges i n nasal, m cosidad nasal, dolor                La pr eba debe reali arse de inmedia o ras la e racci n de la m es ra o en n pla o
de gargan a, mialgia diarrea.                                                                     m imo de na (1) hora desde dicha e racci n.
                                       PRINCIPIO                                                  Para e raer na m es ra median e hisopo nasal:
El es r pido de an genos para el SARS-CoV-2 es n inm noan lisis croma ogr fico                    1. In rod ca con c idado n hisopo nasal es ril, que se
c ali a i o basado en membranas des inado a la de ecci n c ali a i a del an geno de la               suministra en el kit, en n orificio nasal. Median e na
n cleoc pside del SARS-CoV-2 en m es ras h manas ob enidas median e hisopos                          s a e ro aci n, emp je el hisopo nos 2,5 cm desde el
nasales.                                                                                             borde del orificio nasal.
Al procesar las m es ras e incorporarlas al case e de la pr eba, los an genos del SARS-
CoV-2, de haberlos en la m es ra, reaccionar n con las par c las impregnadas de
an ic erpos fren e al SARS-CoV-2, q e se habr n impregnado pre iamen e en la ira
reac i a. A con in aci n, la me cla se despla a hacia arriba por la membrana median e             2. Gire el hisopo cinco eces ocando la m cosa del in erior
acci n capilar. Los complejos conj gados con el an geno se despla an por la ira                      del orificio nasal para garan i ar q e se e raiga         na                                   4 gotas de la
reac i a hacia la ona de reacci n        na l nea de fijaci n median e an ic erpos los                                                                                                                  muestra
                                                                                                     m es ra s ficien e.
cap ra sobre la membrana. Los res l ados de la pr eba p eden obser arse a simple                                                                                                                      procesada
 is a en 15 min os en f nci n de la presencia o a sencia de l neas de color.
Para con ar con n con rol del procedimien o, siempre aparecer na l nea de color en                                                                                                                                            15-30 min.      Negativo   Positivo      No Válido
la regi n de la l nea de con rol para indicar q e se ha a incorporado el ol men de
m es ra adec ado q e la membrana ha a absorbido la s s ancia.
INTERPRETACI N DE LOS RESULTADOS                                              Rendimiento clínico del test rápido de antígenos para el SARS-CoV-2                                                    ndice de símbolos
                            (Cons l e la il s raci n an erior)                                              Método                            RT-PCR            Resultados                                                                     Con iene s ficien e para 
NEGATIVO: solo aparece na l nea de color en la regi n de con rol (C). No aparecen                 Tes r pido de       Resultados       Nega i o      Posi i o     totales                         Fabrican e
                                                                                                                                                                                                                                               pr ebas
l neas de color aparen es en la regi n de la l nea de la pr eba (T). Es o indica q e no se       an genos para el       Nega i o         269            1           270
han de ec ado an genos del SARS-CoV-2.                                                                                                                                                            Diagn s ico in vitro
                                                                                                   SARS-CoV-2           Posi i o          1            33            34                  IVD                                                   Fecha de cad cidad
POSITIVO:* Aparecen dos l neas de color diferen es. Una l nea en la regi n de la l nea                                                                                                            disposi i o m dico
                                                                                                      Resultados totales                 270           34           304
de con rol (C) o ra en la regi n de la l nea de la pr eba (T). Es o indica q e se ha                                                                                                              Cons l ar ins r cciones
de ec ado la presencia de an genos del SARS-CoV-2.                                           Sensibilidad rela i a: 97,1 % (83,8 % - 99,9 %)*                                                                                        LOT       C digo del lo e
                                                                                                                                                                                                  an es de sar
* NOTA: La in ensidad del color de la l nea de la pr eba (T) p ede ariar en f nci n del      Especificidad rela i a: 99,6 % (97,7 % - 99,9 %)*
ni el de an genos del SARS-CoV-2 presen es en la m es ra. Por lo an o, c alq ier             Precisi n: 99,3 % (97,5 % - 99,9 %)*
                                                                                                                                                                                                  L mi e de empera ra                          No re ili ar
 onalidad de color en la regi n de la l nea de la pr eba (T) debe considerarse como n        * 95% Intervalos de confianza
res l ado posi i o.
                                                                                                                               Límite de detecci n
NO V LIDO: no aparece la línea de control. Un ol men ins ficien e de la m es ra o                                                                                                        REF      N mero del ca logo                           Fecha de fabricaci n
                                                                                             El l mi e de de ecci n del es r pido de an genos para el SARS-CoV-2 se es ableci
  n procedimien o incorrec o son los mo i os m s probables para q e no apare ca la
                                                                                               sando dil ciones res ric i as de na m es ra rica inac i a median e irradiaci n
l nea de con rol. Re ise el procedimien o repi a la pr eba con n case e de pr eba
                                                                                             gamma. La m es ra rica se enriq eci con na agr paci n de m es ras nasales                            Represen an e a ori ado en la Com nidad E ropea
n e o. Si el problema persis e, deje de sar el ki de pr eba de inmedia o p ngase en
                                                                                             h manas nega i as en dis in as concen raciones. Cada ni el se some i a pr ebas
con ac o con s dis rib idor local.
                                                                                             rela i as a 30 r plicas. Los res l ados mos raron q e el l mi e de de ecci n es de
                               CONTROL DE CALIDAD                                            1,6 102 TCID50/mL.
                                                                                                                                                                                                                         Tabela de Conte dos
En la pr eba se incl en con roles de procedimien os in ernos. La l nea de color q e            Concentraci n del SARS-CoV-2 en muestra           % Positivo (Pruebas)
aparece en la regi n de la l nea de con rol (C) es n con rol de procedimien os in erno.        1,28*103 TCID50/mL                                100% (30/30)                                  SARS-CoV-2 Antigen                 An geno del SARS-CoV-2
Es a confirma n ni el de m es ra s ficien e q e se ha a sado la cnica de so                    6,4*102 TCID50/mL                                 100% (30/30)
correc a.
                                                                                               3,2*102 TCID50/mL                                 100% (30/30)                                  Negative Control Swab              Hisopo de con rol nega i o
Los hisopos de con rol nega i o posi i o se s minis ran con cada ki . Es os hisopos de
con rol deben sarse para garan i ar q e el case e de la pr eba el procedimien o de             1,6*102 TCID50/mL                                 96,7% (29/30)
la pr eba se empleen de manera adec ada. Siga las indicaciones de la secci n                   8*10 TCID50/mL                                    0% (0/30)                                     Positive Control Swab              T bo del amp n de e racci n
  INSTRUCCIONES DE USO para reali ar la pr eba de con rol.                                                              Interferencia y reactividad cruzada
                                   LIMITACIONES                                              No se obser       reac i idad cr ada con las m es ras de pacien es con agiados con             Extraction Buffer Tubes               T bos del amp n de e racci n
1. El es r pido de an genos para el SARS-CoV-2 es des inado e cl si amen e a                 corona ir s-229E, corona ir s-NL63, corona ir s-OC43, corona ir s-HKU11, 2, ipo de
     n so diagn s ico in vitro. Es a pr eba solo debe sarse para la de ecci n de               ir s de la parainfl en a ( ipo 1, ipo 2, ipo 3    ipo 4), gripe por ir s A/B, rino ir s          Disposable Swabs                  Hisopos nasales es riles
   an genos del SARS-CoV-2 en m es ras ob enidas median e hisopos nasales. La                h mano, boca ir s h mano, ir s sinci ial respira orio h mano, me apne mo ir s
   in ensidad de la l nea de la pr eba no g arda necesariamen e na relaci n con la           h mano, adeno ir s h mano, en ero ir s, Chlam dia pne moniae, Haemophil s                                                            Tes r pido de an genos para el SARS-
   concen raci n rica del SARS-CoV-2 en la m es ra.                                          infl en ae, Legionella pne mophila, M cobac eri m              berc losis, S rep ococc s    SARS-CoV-2 Antigen Rapid Test
                                                                                                                                                                                                                                  CoV-2
2. Las m es ras deben some erse a la pr eba an pron o como sea posible ras s                 pne moniae, S rep ococc s p ogenes, Borde ella per ssis, M coplasma pne moniae,
   e racci n, siempre en n pla o m imo de na hora ras es a e racci n.                        Candida albicans, corona ir s del s ndrome respira orio de Orien e Medio o
                                                                                             Pne moc s is jiro ecii.
3. El so de medios de ranspor e rico p ede conlle ar na red cci n de la
   sensibilidad de la pr eba.                                                                El es r pido de an genos para el SARS-CoV-2 no diferencia en re el SARS-CoV el
                                                                                             SARS-CoV-2.
4. P ede prod cirse n res l ado falso nega i o si el ni el de an genos de la m es ra                                                                                                        ACON Biotech (Hangzhou) Co., Ltd.
   se enc en ra por debajo del l mi e de de ecci n de la pr eba o si la e racci n se         Las s s ancias q e in erfieren (sangre, aerosol de clorhidra o de o me a olina de              No.210 Zhenzhong Road, West Lake                          MedNet GmbH
   reali de forma incorrec a.                                                                dafenlina, aerosol nasal de f roa o de mome asona, propiona o de fl icasona o                  District, Hangzhou, P.R.China, 310030                     Borkstrasse 10
                                                                                             limpiador nasal fisiol gico de ag a marina) con na de erminada concen raci n no                                                                     48163 Muenster, Germany
5. Los res l ados de la pr eba deben combinarse con o ros da os cl nicos de los q e
                                                                                             in erfieren en la pr eba del es r pido de an genos para el SARS-CoV-2.
   disponga el personal m dico.
6. Un res l ado posi i o no descar a coinfecciones con o ros pa genos.                                                               PRECISI N
7. Un res l ado posi i o no diferencia en re el SARS-CoV el SARS-CoV-2.                                                             Intraanalítica
8. Un res l ado nega i o no p ede descar ar o ras infecciones bac erianas o ricas.           La precisi n den ro de na misma serie se de ermin sando 10 r plicas de m es ras:
9. Un res l ado nega i o en pacien es c os s n omas apare can desp s de sie e                con roles posi i os de an genos del SARS-CoV-2 con rol nega i o. Las m es ras se
   d as deber a ra arse como indicio confirmarse con n an lisis molec lar, si f era          iden ificaron correc amen e en m s del 99 % de las ocasiones.
   necesario, para poder reali ar la ges i n cl nica.                                                                               Interanalítica
   (Si es necesario es ablecer na diferenciaci n en re los dis in os ir s cepas              La precisi n en re dis in as series se de ermin sando 10 an lisis independien es de la
   espec ficos del SARS, deber n reali arse o ras pr ebas.)                                  misma m es ra: m es ra posi i a de an genos del SARS-CoV-2 m es ra nega i a. Se
                       CARACTER STICAS DE RENDIMIENTO                                        probaron res lo es diferen es de es s r pidos de an genos para el SARS-CoV-2 con es as
                                                                                             m es ras. Las m es ras se iden ificaron correc amen e en m s del 99 % de las ocasiones.
                   Precisi n, sensibilidad y especificidad clínicas
                                                                                                                                 BIBLIOGRAF A
El rendimien o del es r pido de an genos para el SARS-CoV-2 se es ableci con
304 hisopos nasales e ra dos de pacien es independien es sin om icos (en n pla o             1. Sh o S , Gar Wong, Weifeng Shi, e al. Epidemiolog , Gene ic recombina ion, and
de sie e d as desde la aparici n de los s n omas) de los q e se sospechaba q e p dieran         pa hogenesis of corona ir ses. Trends in Microbiolog , J ne 2016, ol. 24, No. 6:
es ar con agiados con la COVID-19. Los res l ados mos raron q e la sensibilidad                 490-502.
rela i a la especificidad rela i a son las sig ien es:                                       2. S san R. Weiss, J lian L. Leibo i , Corona ir s Pa hogenesis, Ad ances in Vir s                                                                       N mero: 1151248401
                                                                                                Research, Vol me 81: 85-164.                                                                                                          Fecha de en rada en igor: 20 - -
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