ATTACHMENT E - Approved CLIA Test Kits.pdf
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- Attached to
- Rapid HIV Antibody Tests & Control Tests
- Solicitation number
- RFB 758 2200000405 2
- Issued by
- Kentucky
About this file
This document is an attachment listing approved Clinical Laboratory Improvement Amendments (CLIA)-waived rapid HIV test kits suitable for use in non-clinical settings. The document, updated June 11, 2018, provides comprehensive specifications for four primary rapid HIV testing products: Chembio DPP HIV-1/2, Chembio SURE CHECK HIV 1/2 Assay (formerly Clearview COMPLETE as of June 1, 2016), Clearview HIV 1/2 STAT-PAK, and Determine HIV-1/2 Ag/Ab Combo Test, with a partial listing of the INSTI HIV-1/HIV-2 Antibody Test. Each test kit is approved for detecting antibodies to HIV-1 and HIV-2, with the Determine test also detecting HIV-1 p24 antigen. Test results range from 15 to 40 minutes depending on specimen type and reactivity status. Approved specimen types include finger stick whole blood, venous whole blood, and oral fluid swabs, with volumes ranging from 2.5 milliliters to 50 milliliters. Shelf life varies from 15 to 24 months with storage temperature ranges between 36 and 86 degrees Fahrenheit and testing area temperature ranges between 59 and 86 degrees Fahrenheit.
All listed test kits demonstrate high sensitivity and specificity rates, with sensitivity ranging from 99.7 to 99.9 percent for established HIV-1 infection and specificity from 99.7 to 100 percent. The document provides ninety-five percent confidence intervals for each sensitivity and specificity measure and includes manufacturer website links for additional information. This attachment serves as reference material for procurement purposes, establishing the approved CLIA-waived test kits available for use in rapid HIV testing programs within non-clinical settings.
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Updated 06/11/2018 Page 1
Rapid HIV tests suitable for use in non-clinical settings (CLIA-waived) a
Test Name
Time to test result
Indications for use
Sensitivity for established HIV-1 infection, % (95% CI)b
Specificity
% (95% CI)b
CLIA-Waived approved specimen types and volumes
Test kit shelf life/ storage temperature range/Testing area temperature range
Manufacturer web site
Chembio
DPP HIV-1/2
Blood:
between 10 and 25 min Oral fluid:
25-40 min for reactive results and 40 min for non-reactive results
Antibodies to HIV-1 and 2
Finger stick whole blood
99.8 (99.2-99.9) oral fluid
98.9 (98.0-99.4)
Venous whole blood
99.9 (99.4-99.9)
Finger stick whole blood 100 (99.8-100) oral fluid/ venous whole blood
99.9 (99.7-99.9)
Finger stick or venous whole blood 10 μl
Or oral fluid swab
23 months; 36 to 86°F / 64 to 86°F
Link to Chembio
June 1, 2016:
Clearview COMPLETE is now Chembio SURE CHECK HIV 1/2 Assay
15 min Antibodies to HIV-1 and 2
Finger stick or venous whole blood
99.7 (98.9-100.0)
99.9 (99.6-100.0)
Finger stick or venous whole blood
2.5 μL
24 months; 46 to 86°F/
Clearview HIV 1/2
STAT-PAK
15 min
99.7 (98.9-100)
99.9 (99.6-100.0)
Finger stick or venous whole blood 5 μL
24 months; 46° to 86° F/
Updated 06/11/2018 Page 2 test result infection, % (95% CI)b
Specificity
% (95% CI)b
CLIA-Waived approved
Determine HIV-1/2 Ag/Ab Combo Test
20 min
Antibodies to HIV-1 and
HIV-2, Detects HIV-1 p24 Antigen
99.9 (99.4-100)
Finger stick whole blood:
Low risk subjects 100 (99.5-100), High risk subjects
99.7 (98.9-100)
Finger stick whole blood 50 μL
15 months; 36-86°F/ 59-86°F
Link to ALERE now Abbott
INSTI HIV-1/HIV-2
Antibody Test
<2 min
99.8 (99.3-99.9)
Overall from low, high and unknown risk individuals
99.5 (99.0.9-99.8)
50 μl
15 months; 59-86°F/ 59-86°F
Link to bioLytical
OraQuick ADVANCE
Rapid HIV-1/2 Antibody Test
20 min Antibodies to HIV-1 and 2
Oral fluid
99.3 (98.4-99.7) finger stick whole blood (venous whole blood not evaluated)
99.6 (98.5-99.9)
Oral fluid
99.8 (99.6-99.9), finger stick whole blood (venous whole blood not evaluated) 100 (99.7-100)
Finger stick or venous whole
5μl or oral fluid swab
12 Months; 36-80°F/ 59-99°F
Link to OraSure
Updated 06/11/2018 Page 3 test result infection, % (95% CI)b
Specificity
% (95% CI)b
CLIA-Waived approved
Uni-Gold
Recombigen
HIV-1/2
10 min Antibodies to
HIV-1 and
HIV-2
Finger stick or venous whole blood
100 (99.5-100.0)
Finger stick or venous
99.7 (99.0-100)
Finger stick or venous whole
50 μL
12 months; 35.6-80.6°F/ 59-80.6°F
Link to Trinity Biotech a CLIA-waived rapid tests can be used in settings such as: community-based organizations, field testing, outreach activities, STD or other clinics, mobile clinics, non-traditional testing, or community/college clinics. The Clinical Laboratory Improvement Amendments (CLIA) sets criteria based on complexity levels of tests. Briefly, there are three levels of complexity: 1) Waived – simple, low-risk tests that can be performed with minimal training that do not require centrifugation of specimens for testing, 2) Moderate Complexity – simple tests that use plasma or serum specimens (must participate in an external proficiency testing program), 3) High Complexity – tests that require trained laboratory personnel, involve multiple-step protocols, frequent quality control, and participation in an external proficiency testing program. For more information about CLIA regulations go to Link to CLIA Regulations.
b Sensitivity is a measure of the test’s ability to correctly identify persons with a disease. Specificity is the test’s ability to correctly identify persons without the disease.
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