INSTI HIV-1 HIV-2 Antibody Test Kit - BioLytical Laboratories

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                                                                                                      Document Number:
INSTI HIV-1 HIV-2 Antibody Test Kit –                                                                 PROV-120
BioLytical Laboratories                                                                               Version Number: 1

                                                                                                      Approved Date:
                                                                                                      July 8, 2021
Approving Authority (Sponsor): Microbiology Discipline Leads                                          Next Review Date:
Clinical Standard Owner: Director – Clinical Quality Safety Logistics                                 July 8, 2022
Contact for Interpretation: LQR@saskhealthauthority.ca
Healthcare providers eligible to perform this function: Qualified          Document Type:
professionals as indicated by Lab License (May include: Medical            Procedure – Laboratory Medicine
Laboratory Professional, Registered Nurse, Licensed Practical Nurse,
Respiratory Therapist, Paramedic, Registered Psychiatric Nurse, Physician,
or a Nurse Practitioner and Physical Therapist)
Key words: HIV, HIV POC, HIV POCT, INSTI Kit, Point of Care

1.        PURPOSE

          To provide instruction on how to perform HIV Point of Care testing.

          A reactive INSTI test result should be considered a preliminary result, with appropriate
          counseling provided in point-of-care (POC) settings. Following a reactive, indeterminate or
          invalid rapid test result, a venous blood sample must be drawn and forwarded to the Roy
          Romanow Provincial Laboratory (RRPL) for HIV additional testing.

2.        PRINCIPLES

          The INSTI™ HIV-1/HIV-2 Antibody Test is a single use, rapid, flow-through in vitro qualitative
          immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and
          Type 2 in human EDTA whole blood, EDTA plasma, fingerstick blood or serum. The test is
          intended for use by trained personnel in medical facilities, clinical laboratories, emergency care
          situations, and physicians’ offices as a diagnostic test capable of providing results in less than
          one minute. Although suitable for near-patient or POC testing, the INSTI HIV-1/HIV-2 Antibody
          Test is not suitable for home testing. All required pre- and post-test counselling guidelines must
          be followed in each setting in which the INSTI HIV-1/HIV-2 Antibody Test is used.

                                                                                                                                   Page 1 of 19

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:
3.        ROLES AND RESPONSIBILITIES

              HIV POC testing is beneficial where immediate knowledge of patient’s HIV statue is
              considered important. Criteria for testing can be found in The Guidelines for the Use of HIV
              Point of Care (POC) Test Kits in Saskatchewan on the RRPL Compendium of Tests: https://rrpl-
              testviewer.ehealthsask.ca/ or
              https://publications.saskatchewan.ca/api/v1/products/11997/formats/81578/download.

          3.1        May include: Medical Laboratory Professional, Registered Nurse, Licensed Practical
                     Nurse, Respiratory Therapist, Paramedic, Registered Psychiatric Nurse, Physician, or a
                     Nurse Practitioner and Physical Therapist

                           Perform and complete testing in facilities where testing has been implemented
                           Participate and complete required training. See Appendix E: Laboratory Test or
                                 Instrument General Training Checklist
                           Perform patient analysis, run external Quality Assurance, perform internal QC and
                            follow QC procedures, troubleshooting and maintain competency, follow
                            accreditation requirements
                           Qualified employees will undergo training to perform INSTI HIV-1/HIV-2, including
                            but not limited to reading the procedure and demonstration of test being
                            performed
                           During initial training, each employee will physically run controls, not just observe
                            test being performed. Results of this initial control run will be recorded.
                           Only after successful completion of training with control runs passing, an employee
                            is able to test patients
                           After competency has been established, each employee will observe the test being
                            run at minimum every 6 months and perform kit controls or external quality
                            controls from the College of Physicians and Surgeons every 12 months
                           Document all observed and physical run controls by each employee with supervisor
                            sign-off for proof of proficiency which can be produced during inspections, as
                            requested. Refer to Appendix A: HIV POCT Quality Control Log

          3.2        Manager/Supervisors

                           Ensure that proficiency testing has been performed and reported
                           Train all users. See Appendix E: Laboratory Test or Instrument General Training
                            Checklist
                           Retain documentation of staff training and competency of staff
                           Manage supplies, controls and proficiency testing
                           Ensure training for all new staff that would perform test
                           Ensure competency of all staff that will perform test
                           Sign-off all training and competency documentation

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 2 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:

4.        SPECIMEN INFORMATION

 Specimen Type/Source                              EDTA-whole blood, EDTA-plasma, serum, fingerstick sample (capillary)
 Acceptable Collection Containers                  Lavender-top EDTA (anticoagulant tubes), red-top (no anticoagulant
                                                   tube), yellow-top SST serum tubes (validated at RRPL)
 Minimum Requirements                              50μl of whole blood, plasma or serum for testing
 Specimen Stability                                 If plasma or serum is being used, separate from the blood cells by
                                                      centrifugation
                                                    Serum or EDTA-plasma is stable at 2-8°C for up to 5 days
                                                    Do not heat or repeatedly freeze/thaw specimens
                                                    Whole blood EDTA is stable at 2-8°C and should be tested within 48
                                                      hours
                                                    Do not heat or freeze whole blood specimens
                                                    Fingerstick sample must be tested immediately
 Storage Requirements                               Serum or EDTA-plasma - stored frozen at ≤ -20°C for 3 months, or
                                                      stored frozen at ≤ -70°C for one year
                                                    Whole blood can not be frozen or stored
                                                    Fingerstick samples can not be frozen or stored
 Specimen Handling                                 Do not dilute or pool samples prior to testing

5.        EQUIPMENT & SUPPLIES, REAGENTS, FORMS & LABELS

 Equipment & Supplies                                     Reagents                                                 Forms & Logs
  BioLytical Kit and components:                         INSTI Reagents                                            Appendix A:
    Membrane unit, Sample Diluent,                             Membrane Unit                                         HIV POCT Quality
    Color Developer, Clarifying                                Sample Diluent (solution 1)                           Control Log
    Solution, alcohol swab, lancet,                            Color Developer (solution 2)                        Appendix B:
    single-use capillary pipette                                                                                      HIV POCT Incident Log
                                                               Clarifying Solution (solution 3)
  Personal protective equipment                                                                                    Appendix C:
  Biohazard waste containers                                                                                         HIV POCT Result Log
                                                          INSTI HIV-1/HIV-2 Test Controls:
  Precision pipette (50μl) or single-                                                                              Appendix D:
                                                          Ordered separately
    use bulb pipette                                                                                                  HIV Point of Care
  Absorbent cotton balls                                      HIV-1                                                 Supply Requisition
  SHA approved                                                HIV-2
    cleaner/disinfectants                                      Negative

 For Venipuncture Blood Collection
  Venipuncture collection supplies
  Lavender-top EDTA or serum
     blood collection tubes

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 3 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:

6.        REAGENT INFORMATION

                                 Membrane Unit                      Sample Diluent                 Color Developer              Clarifying Solution
                                                                      (solution 1)                   (solution 2)                  (solution 3)
 Appearance                  White square plastic              Clear                             Blue                         Clear
                             unit with inner circle
                             membrane inside a
                             well
 Preparation                 Ready to use            Ready to use. Sample Ready to use,        Ready to use, no
                                                     is added to this      invert 2-3X         mixing or
                                                     container and mixed immediately           preparation
                                                     by inversion.         before use.         required
 Number of uses              Single use only         Single use only       Single use only     Single use only
 Kit Information              Do not mix reagents from different lots
                              INSTI components should be stored at 2-30oC
                              Do not use reagents or kits beyond the stated expiration date
                              Adding an excessive amount of specimen may cause the device to overflow or leak
                              Do not use the Membrane Unit if the foil pouch has been previously opened or if the
                                 packaging integrity has been compromised. Once the Membrane Unit has been
                                 opened, it must be used immediately
                              Controls are not contained in the kit and must be ordered separately

7.        SAFETY PRECAUTIONS
          7.1  Hazards

               Treat all patient specimens as highly infectious
               Puncture hazard working with venipuncture collection supplies and lancets

          7.2        Safe Work Practices

               Use proper technique to not contaminate yourself, nor create aerosols
               All laboratory personnel shall don required personal protective equipment, as per standard
                precautions, prior to performing the task(s) outline in this standard operating procedure, as
                per Job Safety/Hazard Analysis
               Thoroughly wash hands after handling or performing this test
               Do not smoke, eat, or drink in areas where specimens or kit reagents are being handled
               Do not pipette by mouth
               Avoid contact with skin and eyes. If contact occurs, wash affected areas with water
               Avoid forming aerosols
               Dispose of all specimens and materials as biohazardous waste
               Spills should be cleaned up and decontaminated in accordance with the user facility’s
                established procedures for handling biohazardous spills
Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 4 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                               Date Approved: July 8, 2021
                                                                                                             Date Revised:
8.        QUALITY CONTROL

 Quality Control                   Internal Quality Control: The INSTI HIV-1/HIV-2 Antibody Test has a built-in IgG
                                   capture procedural control that demonstrates assay validity and adequate sample
                                   addition. A blue color in the control spot indicates that the proper specimen was
                                   added and that the assay procedure was performed correctly. The control spot will
                                   appear on all valid INSTI tests. (Refer to Interpretation of Results, below.)
 Control Criteria                  Three levels of Kit Controls: HIV-1, HIV-2 and Negative (supplied separately): The
                                   controls are used to verify test performance and interpretation of results. Kit
                                   controls must be run under the following circumstances:

                                         For new INSTI user verification
                                         When switching to new lot number of INSTI test kits
                                         Whenever a new shipment of kits is received (same or different lot number)
                                         When temperature during storage of the kit falls outside of 2-30°C
                                         When the temperature of the test area falls outside of 2-30°C
                                         If a site conducts >24 point-of-care tests per day, the controls should be run
                                          every day
                                         If a site conducts
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                               Date Approved: July 8, 2021
                                                                                                             Date Revised:
 Alternate QC                      Proficiency Testing in addition to QC
 Measures
 Storage of QC Data                2 years
 Initial HIV POC                   Initial set-up of becoming an HIV Point of Care location.
 location setup                    Instructions on How to Set Up an HIV Point of Care Site v4.0.pdf (ehealthsask.ca)

9.        PROCEDURE

 Step        Action
     1       Obtain kit and bring to room temperature before performing the test.

             Note: All Test Units are single use only and must be used immediately once opened. All reagents
             should be dispensed evenly in the center of the well. Once test is completed, dispose components
             into appropriate biohazard container.
      2      Gather support materials (swab, lancet, pipette), one sealed test pouch containing INSTI Membrane
             Unit, and one vial each of the Sample Diluent (solution 1), Color Developer (solution 2), and
             Clarifying Solution (solution 3) for each test to be performed.
      3      Collect specimen
             If                     Then
             Sample                 Caution: The amount of sample (fingerstick blood) is critical.
             Fingerstick
             Blood                  To ensure that the proper amount of blood is achieved, follow these instructions
                                    carefully:

                                    o      Label Sample Diluent vial and tab of membrane unit with control or patient
                                           information
                                    o      Massage the finger to allow the blood to move to the surface (fingertip will
                                           become pink). Use heating pad if available to warm the hand. Hand must be
                                           positioned at waist level or lower.
                                    o      Wipe the fingertip with the alcohol swab
                                    o      As soon as the finger is dry, twist off the protective cap from the lancet, and
                                           then pull it straight out. Press the finger firmly at the point just below where
                                           the lancet will be applied. With the other hand, hold the lancet by the body
                                           and press the lancet body firmly against the puncture site to activate the
                                           device. Immediately dispose the used lancet into a proper sharps container.
                                    o      As the blood bubbles up, hold the capillary pipette horizontally and touch the
                                           tip of the pipette to the blood sample. Capillary action automatically draws the
                                           sample to the fill line and stops. If very little blood trickles out of the puncture,
                                           gently apply intermittent pressure near the puncture site to obtain the
                                           required blood volume. If blood is inadequate, perform a second skin puncture
                                           using a new lancet.

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 6 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                               Date Approved: July 8, 2021
                                                                                                             Date Revised:

                                                                                  Capillary Pipette

                                    CAUTION! Filling is automatic: Never squeeze the capillary pipette while sampling.

                                    o      Transfer the blood held in the pipette to the Sample Diluent vial (solution 1).
                                           Align the tip of the capillary pipette with the Sample Diluent vial and squeeze
                                           the bulb of the capillary pipette to dispense the sample. Note: If the sample
                                           will not expel, hold the capillary pipette vertically and slide a finger over
                                           (without pressing) the vent hole, then squeeze the bulb. Recap the vial and
                                           mix by inversion. Proceed to step 4, below.

             Sampling               Collect EDTA-whole blood, EDTA-plasma or serum specimens, follow normal
             EDTA Whole             venipuncture blood collection procedures using lavender-top EDTA anticoagulant
             Blood,                 tubes (for whole blood and plasma), or red-top (no anticoagulant) or yellow-top SST
             serum, EDTA-           tubes for serum. If plasma or serum is to be used, separate from the blood cells by
             plasma and             centrifugation.
             Test Controls
                                    Bring specimens to room temperature and mix each specimen thoroughly prior to
                                    use. Do not heat or repeatedly freeze/thaw specimens.

                                    Label Sample Diluent vial and tab of membrane unit with control or patient
                                    information.

                                    Using a pipette, add 50μl using precision or bulb pipette of whole blood, serum,
                                    plasma, or kit controls (see Note) to the Sample Diluent (solution 1) vial. Recap the
                                    vial and mix by inversion. Adding an excessive amount of specimen may cause the
                                    device to overflow or leak. Proceed to step 4, below.

                                                                                      Bulb Pipette

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 7 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:
                                    Note: In POC settings, for INSTI kit controls, it is important to use a 50μl precision or
                                    bulb pipette device to add the control material to the Sample Diluent vial. Do not
                                    use the disposable single-use capillary pipette provided for fingerstick blood
                                    collection.
      4      Perform test

                  Tear open the pouch and carefully remove the single use Membrane Unit without touching the
                   center well.
                  Place the unit on a level surface. For sample identification purposes, the tab of the Membrane
                   Unit may be labelled with the control or patient’s identifier.

                   NOTE: At this point, it is important that the following steps be performed immediately and in
                   sequence

                  Remix the Sample Diluent-specimen mixture and pour the entire contents to the center of the
                   Membrane Unit well. (Note: Do this within 5 minutes after the specimen has been added to the
                   Sample Diluent vial). The sample should be absorbed through the membrane in less than 30
                   seconds; however, absorption times will vary slightly depending upon sample type.
                  Re-suspend the Color Developer by slowly inverting to mix the solution thoroughly. Continue
                   this process until careful visual observation confirms that the reagent is evenly suspended.
                   Open the Color Developer and add the entire contents to the center of the Membrane Unit
                   well. The colored solution should flow through completely in about 20 seconds.
                  Open the Clarifying Solution and add the entire contents to the center of the Membrane Unit
                   well. This will lighten the background color and facilitate reading. Immediately read the result
                   while the membrane is still wet. Do not read the results if more than 5 minutes has elapsed
                   following the addition of Clarifying Solution. If more than 5 minutes have elapsed, repeat the
                   test.

10.       INTERPRETATION OF RESULTS AND EXPECTED VALUES

 Interpretation of Results:                 Do not read the results if more than 5 minutes has elapsed following the
                                            addition of Clarifying Solution. If more than 5 minutes have elapsed, repeat
                                            the test. If using the control samples provided by the Roy Romanow Provincial
                                            Laboratory, all positive controls must be reactive with INSTI and all negative
                                            controls must be non-reactive with INSTI. Controls that produce incorrect or
                                            invalid results must be re-tested with INSTI. If control results are still incorrect
                                            or invalid, inform Roy Romanow Provincial Laboratory immediately.
     Non-Reactive                          One blue dot that is clearly discernable above any background tint should
                                            appear on the membrane. This is the procedural Control Spot and shows that
                                            the test has been performed correctly. The Control spot location is indicated
                                            by the letter C. No reaction should be visible at the test spot, located below
                                            the control. A non-reactive result indicates that antibodies to HIV-1/HIV-2
                                            were not detected in the specimen.

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 8 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:

     Reactive                              Two blue dots that are discernable above any background tint indicate that
                                            the specimen contains HIV-1/HIV-2 antibodies. One dot may be darker than
                                            the other. A sample giving this pattern is considered a preliminary reactive.
                                            Following a reactive rapid test result, a venous blood sample must be drawn
                                            and forwarded to the Roy Romanow Provincial Laboratory for HIV additional
                                            testing, see Section 11. Additional Testing Information.

     Invalid                               The test is invalid if any of the following occurs:
                                              There is no dot on the membrane
                                              The test dot appeared without the control dot
                                              Uniform tint across the membrane
                                              Only blue specks appear on the membrane

                                            Note: Invalid tests with fingerstick blood samples in POC settings should be
                                            repeated with a fresh sample using a new membrane unit, kit components
                                            and support materials. Invalid tests with EDTA whole blood, EDTA plasma or
                                            serum samples in laboratory settings should be repeated using a new
                                            membrane unit and kit components.

                                            Note: If a patient has two consecutive invalid INSTI test results, a venous
                                            blood sample must be drawn and forwarded to the Roy Romanow Provincial
                                            Laboratory for HIV additional testing, see Section 11. Additional Testing
                                            Information.
Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                       Page 9 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:
     Indeterminate                         The test is indeterminate if a faint background ring appeared on the test area.
                                            Following an indeterminate INSTI test result, a venous blood sample must be
                                            drawn and forwarded to the Roy Romanow Provincial Laboratory for HIV
                                            additional testing, see Section 11. Additional Testing Information.

 Interpretation Notes:

     Depending on the antibody titer, a reactive specimen may be less intense in color than the procedural
      control, or vice versa.
     Only a blue spot of color discernibly darker than the background color should be interpreted as reactive
      or positive. Only tests exhibiting distinct fully formed blue test dot combined with a distinct fully formed
      blue control dot should be interpreted as reactive. Color intensity may be variable within or between
      the dots.
     The absence of a distinct control dot usually indicates that the sample volume was insufficient.
     A test resulting in a uniform blue tint across the entire membrane, thus obscuring the control and test
      spots, can occur when more than 60uL of whole blood is used and the flow through the assay membrane
      is obstructed.
     An individual who has a non-reactive result but was involved in HIV-risk is likewise recommended to
      obtain additional testing over the next months.

11.       ADDITIONAL TESTING INFORMATION

          For reactive, indeterminate and two invalid INSTI test result, forward sample to Roy Romanow
          Provincial Laboratory for additional HIV testing.
               Sample collection, refer to the RRPL Compendium for additional details.
                       o Serum (SST) - venous blood sample follow normal venipuncture blood collection
                           procedures and centrifuge before shipping.
                       o Lavender-top EDTA plasma - venous blood sample follow normal venipuncture
                           blood collection procedures. Centrifuge and remove plasma from cells before
                           shipping.
               Order HIV Screen test on requisition.
               Sample must be shipped Category B, UN3373 and in appropriate shipping containers.
               Only employees with valid TDG 6.2 certificates are able to ship samples.
               If HIV Viral Load testing is also required, send an additional requisition and frozen EDTA
                  plasma, according to HIV Viral Load protocol. Remove plasma from cells and freeze
                  before shipping. Samples must be sent and received frozen. Please refer to the RRPL
                  Compendium for additional collection and shipment details.

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                     Page 10 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:
12.       METHOD LIMITATIONS

                In some instances, samples may exhibit longer than normal flow times (from the time the
                 Sample Diluent specimen mixture is poured in the membrane well to the time the
                 Clarifying Solution has fully flowed through the membrane). This is due to variable factors
                 such as cellular components, especially with whole blood. In instances of long flow times,
                 a faint shadow in the form of a ring may appear at the test spot location, but th is should
                 not be interpreted as a reactive result. This should be considered as an indeterminate
                 result. In these instances, a venous blood sample must be drawn and forwarded to the Roy
                 Romanow Provincial Laboratory for HIV additional testing, see Section 11. Additional
                 Testing Information.
                The INSTI HIV-1/HIV-2 assay procedure and the interpretation of result must be followed
                 closely when testing for the presence of antibodies to HIV in serum, plasma or whole
                 blood.
                Absence of antibodies to HIV does not indicate that an individual is absolutely free of
                 HIV-1 or HIV-2; HIV has been isolated from seronegative individuals prior to
                 seroconversion.
                Insufficient data are available to interpret tests performed on other body fluids, pooled
                 blood or pooled serum and plasma, or products made from such pools; therefore, testing
                 of these specimens is not recommended.
                The INSTI HIV-1/HIV-2 assay has not been validated for detection of antibodies to HIV-1
                 Group N subtypes.
                Additional test limitations, warnings and performance characteristics of test can be located
                 in the package insert.
                The INSTI HIV-1/HIV-2 assay detects antibodies to HIV-1/HIV-2 and is useful in establishing
                 infection with HIV. Because a variety of factors may cause non-specific reactions, a patient
                 found to be positive using the INSTI HIV-1/HIV-2 assay should have a sample drawn for
                 laboratory-based additional testing. A person who has antibodies to HIV is presumed to be
                 infected with the virus and appropriate counseling and medical evaluation should be
                 offered.

13.       MATERIALS MANAGEMENT

          BioLytical INSTI HIV-1/HIV-2 Antibody Test Kits and controls can be ordered through the Roy
          Romanow Provincial Laboratory. Refer to Appendix D: HIV Point of Care Supply Requisition.

14.       PROCEDURE MANAGEMENT

          The management of this procedure including procedure communication, education,
          implementation, evaluation and audit is the responsibility of Laboratory Quality and Regulatory
          Manager, Regina Area. Renewal and amendment is the responsibility of the Laboratory Quality
          and Regulatory Manager, Regina Area and Laboratory Quality Safety and Logistics Director.

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                     Page 11 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:

15.       REFERENCES

             BioLytical Laboratories INSTI HIV-1/HIV-2 Antibody Test package insert 51-1028N, 19-Sept-
              2019
             The Laboratory Biosafety Guidelines, 3rd Edition. Office of Laboratory Security, Health
              Canada. 3.1.2, 2004.
             Instructions on How to Set Up on HI Point of Care Site
             Instructions on How to Set Up an HIV Point of Care Site v4.0.pdf (ehealthsask.ca)
             Guidelines for the use of HIV Point of Care (POC) Test Kits in Saskatchewan, 2017
              on the RRPL Compendium of Tests: https://rrpl-testviewer.ehealthsask.ca/ or
              https://publications.saskatchewan.ca/api/v1/products/11997/formats/81578/download
             RRPL Compendium of Tests: HIV Viral Load (NAAT)
              https://rrpl-testviewer.ehealthsask.ca/Home/Details?id=228

16.       ASSOCIATED/SUPPORTING DOCUMENTS
 Document #                Policy/Procedure/Form/Document Title
 SHA-02-002                Safety Reporting/Stop the Line
 PROV-15                   Safety Practices during Pandemic
 MM003F V2 Doc             HIV Point of Care Supply Requisition
 1400-55

17.       APPENDICES

          Appendix A: HIV POCT Quality Control Log
          Appendix B: HIV POCT Incident Log
          Appendix C: HIV POCT Result Log
          Appendix D: HIV Point of Care Supply Requisition
          Appendix E: Laboratory Test or Instrument General Training Checklist
          Appendix F: Repealed Policies, Procedures, Forms and Other Related Documents

 SHA accepts no responsibility for use of this material by any person or organization not associated with SHA. No part of this document may
 be reproduced in any form for publication without permission of SHA.

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                     Page 12 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
APPENDIX A: HIV POCT QUALITY CONTROL LOG
Quality Control Log – INSTI HIV-1 HIV-2 Antibody Test Kit
Location _______________                       Site_______________                          Month_____________                           Year______________

  Date      QC Material        QC Lot #          Test Kit Lot #             Results                   Tester ID                OK        Observed or              Supervisor Review
                                                                                                                                         run controls

                                                                                                                         Page 13 of 19

                    Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                                                                                   Date Approved: July 8, 2021
                                                                                                                                                                 Date Revised:

                                                                      APPENDIX B: HIV POCT INCIDENT LOG
Incident Log - INSTI HIV-1 HIV-2 Antibody Test Kit
Location _______________                            Site_______________                          Month_____________                           Year______________

   Date           Type of Incident (QC failure, device                                  Description                                       Action Taken                      Date Resolved
                   failure, EQA discrepancy, parallel
                          testing Discrepancy

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories                                                                                 Page 14 of 19
Number/Version: PROV-120 V#: 1

                         Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                                                                                   Date Approved: July 8, 2021
                                                                                                                                                                 Date Revised:

                                                                       APPENDIX C: HIV POCT RESULT LOG
Result Log - INSTI HIV-1 HIV-2 Antibody Test Kit

  Date test         Lot #           Test kit                          Patient ID                             Tester ID                 ID of staff                          Test results
 performed                        expiry date                                                                                      verifying results
                                                                                                                                     (if available)

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories                                                                                 Page 15 of 19
Number/Version: PROV-120 V#: 1

                         Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
APPENDIX D: HIV POINT OF CARE SUPPLY REQUISTION

                                                                                                                                 Page 16 of 19

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                               Date Approved: July 8, 2021
                                                                                                             Date Revised:
              APPENDIX E: LABORATORY TEST OR INSTRUMENT GENERAL TRAINING CHECKLIST

Name: __________________________________________

Department: _____________________________________

Location: ________________________________________

Test or Instrument: ________________________________

 (Circle any areas that you feel you did not completely understand or were not shown. Mark N/A if not applicable)
                         (Please return completed form to your supervisor for filing)

Documentation                                                                       Trainee      Trainer      Additional Comments
                                                                                    Date/Initial Date/Initial Trainers
                                                                                                              Date/Initial
    a. Read procedure
    b. Read package insert
    c. Watch training video
    d. Reviewed SDS
    e. Review Job Safety Analysis
Performing Test
    a. Required supplies, reagents, labels and forms
    b. Reagent preparation or kit information
    c. Watch trainer perform test or operate instrument
    d. Trainee to perform test or operate instrument
        under direct observation
    e. Run parallel runs (trainee and trainer both run test
        and compare results) – document runs
    f. Quality Control parameters and procedure if out
        of range
    g. Calibrations
    h. Result entry and authorizing
    i. Any strict time parameters for test
    j. Abnormal result procedure or considerations
    k. Maintenance requirements
    l. Proficiency Panels
    m. Troubleshooting
Safety Considerations
    a. PPE requirements
    b. Instrument hazards
    c. Sample hazards
    d. Other hazard or safety equipment (BSC)
    e. Reagent or sample disposal

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                      Page 17 of 19
Number/Version: PROV-120 V#: 1

 Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                               Date Approved: July 8, 2021
                                                                                                             Date Revised:
Sample Processing                                                         Trainee         Trainer       Additional Comments
                                                                          Date/Initial Date/Initial Trainers
                                                                                                        Date/Initial
    a. Acceptable samples for testing (urine, serum or
         plasma)
    b. Proper preparation prior to testing & problems
         resulting from improper preparation
    c. Sample volume required
    d. Sample stability
    e. Sample storage requirements
General Information and Prioritization
    a. Cleaning and restocking
    b. Kit or reagent re-order points
    c. Procedure for mislabeled or unlabeled specimens
    d. Review handling patient demographic
         discrepancies
    e. Priority of samples
    f. Expected turn-around times
    g. Workflow for instrument or test
Additional
    a. Extra coaching required or training issues -
         document
    b. Competency assessment in 6 months
Test or Instrument Specific Training Items
    a.
    b.
    c.
    d.
    e.
Comments or Concerns
    a.
    b.
    c.
    d.
    e.
Competency has been met          Yes      No (if no, state remedial plan to meet standards)                                                Date
Approving Supervisor/Designate
Director/Manager/Designate (when required)
Remedial Plan to Meet Standards (if competency has not been met)

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                      Page 18 of 19
Number/Version: PROV-120 V#: 1

 Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical Laboratories (PROV-120, Version 1)
                                                                                              Date Approved: July 8, 2021
                                                                                                            Date Revised:
              Appendix F: Repealed Policies, Procedures, Forms and Other Related Documents

           This policy replaces or partially replaces the following former regional health authority policies,
           procedures, forms or other related documents including but not limited to:

Policy Name (Policy Number) Full Repeals
 Name of former        Policy/Procedure/Form/Document Title                                                                Document #
 health region
 Mamawetan             HIV Quality Control Log                                                                             Gen.3.1.A1
 Mamawetan             HIV Patient Result Log                                                                              Gen.3.1.A3
 Prince Albert         HIV Screening                                                                                       VH-CH-145
 Prince Albert         HIV Screening                                                                                       VH-CH-10-52
 Prairie North         Policy and Procedure for Point of Care Testing                                                      PHU 002-2019
 Prairie North         HIV POC Quality Control Log INSTI HIV-1 Antibody Test Kit                                           RLS.POC.19
 Prairie North         HIV POC Incident Log INSTI HIV-1 Antibody Test Kit                                                  RLS.POC.19
 Regina RRPL           INSTI HIV-1-HIV-2 Antibody Test Kit BioLytical Laboratories                                         Doc 25000-00
                                                                                                                           IMM 900 V5

Policy Name (Policy Number) Partial Repeals
 Name of former        Policy/Procedure/Form/Document Title                                                                Document #
 health region
 Mamawetan                        HIV POCT (Point of Care Testing)                                                         Gen.3.1
 Prairie North                    INSTI HIV-1 Antibody Test Kit – BioLytical Laboratories                                  RLS.POC.19
 Regina                           HIV Point of Care (POC) Testing and Test Kits, Guidelines for
                                  Use
 Saskatoon                        HIV POCT                                                                                 CHEM-222 v1

Procedure: INSTI HIV-1 HIV-2 Antibody Test Kit – BioLytical
Laboratories                                                                                                                     Page 19 of 19
Number/Version: PROV-120 V#: 1

Any PRINTED version of this document is only accurate up to the date of printing July 9, 2021; see Laboratory Quality Staff for current version.
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