INSTI HIV-1 HIV-2 Antibody Test Kit - BioLytical Laboratories
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Clinical Procedure
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 conductsINSTI 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.You can also read
