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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