Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities

Disclaimer: The following are DRAFT strategies for potential use in point of care (POC) settings for the detection of HIV infections. These strategies were developed by convened panels of multidisciplinary HIV diagnostic subject matter experts. The strategies have not been validated and are not currently recommended by the Association of Public Health Laboratories or the Centers for Disease Control and Prevention for use in POC testing. They should not be used as the basis for reporting results to a client. This document is solely intended to solicit data that may help to validate the strategies for the diagnosis of HIV. The numbered footnotes in the diagrams reference the accompanying lists of specific data needs identified for each strategy. These data needs can be found on the page following each strategy diagram.

Key to Symbols
+ = Reactive - = Non-Reactive

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities
Strategy 1: Single Rapid Test (A1) for HIV Screening.

A1
(HIV-1 or HIV-1/2 rapid test (Oral Fluid or Blood))

A1+ Preliminary positive for HIV-1 or HIV-2 antibodies; requires supplemental laboratory testing 1, 2, 3

A1 Negative for HIV-1 and HIV-2 antibodies*4

*If using an HIV-1 only rapid test, Negative for HIV-1 antibodies only

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities Data Needs for Strategy 1:
1) Data for specimens with a reactive rapid test (A1) on one or more of the following: Number and percentage of persons who fail to receive laboratory-based supplemental results. Number and percentage of persons with preliminary positive rapid test results who are in medical care within six months of this reactive test. 2) Performance data of Nucleic Acid Amplification Testing (NAAT) as a supplemental test for preliminary positive rapid tests. 3) Number and percentage of specimens with preliminary positive rapid tests that are false positive as determined by laboratory-based supplemental testing. 4) Number and percentage of specimens with negative rapid tests (A1) that are determined to be false negative by acute infection screening; and/or the impact of using risk-based criteria for acute infection screening.

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities
Strategy 2: Two Rapid Tests (A1/A2) Performed in Sequence on Blood. (A1 and A2 must be different rapid tests.)

A1
[HIV-1 or HIV-1/2 rapid test (Blood)]

A1+ A2

A1Negative for HIV-1 and HIV-2 antibodies*3

[HIV-1 or HIV 1/2 rapid test from a different manufacturer (blood)]

A1+ A2+ Presumptive positive for HIV-1 or HIV-2 antibodies; requires medical follow-up for further evaluation and testing1, 2

A1+ A2Inconclusive rapid test result; requires additional testing

4, 5

*If using an HIV-1 only rapid test, Negative for HIV-1 antibodies only

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities Data needs for Strategy 2:
1) Number and percentage of false positive strategy results (i.e., A1+, A2+ in truly uninfected persons) as determined by further clinical evaluation and/or laboratory-based supplemental testing including false positive rates for test combinations that may have the same antigenic components. 2) Number and percentage of persons referred to medical care based on presumptive positive rapid test results who are in medical care within six months of receiving the results. 3) Number and percentage of specimens with negative rapid tests (A1) that are determined to be false negative results by acute infection screening; and the impact of using riskbased criteria for acute infection screening. 4) Number and percentage of specimens with inconclusive rapid test results for one or more of the following: With false positive A1 results as determined by laboratory-based supplemental testing With false negative A2 results as determined by laboratory-based supplemental testing 5) Whether a change in the message a client receives from a counselor on discordant rapid test results influences the return rate of clients to receive their laboratory test results. For example: We did two different tests today, one was positive for HIV antibody and one was negative, and we really dont know if youre infected so you need to come back next week for your laboratory test results.

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities
Strategy 3. Two Rapid HIV Tests (A1/A2) Performed in Sequence: First Test, A1 Performed on Oral Fluid and Repeated (when A2 is negative) on Blood. (A1 and A2 must be different rapid tests)**

A1
[HIV-1 or HIV-1/2 rapid test (Oral Fluid)]

A1+

A1Negative for HIV-1 and HIV-2 antibodies*3

A2
[HIV-1 or HIV 1/2 rapid test from a different manufacturer (Blood)]

A1+ A2+ Presumptive positive for HIV-1 or HIV-2 antibodies; requires medical follow-up for further evaluation and testing 1,2

A1+ A2A1
(HIV-1 or HIV 1/2 rapid test repeated on Blood)

A1(oral fluid)+ A2- A1(blood)+ Inconclusive rapid test result; requires additional testing4,6

A1(oral fluid)+ A2- A1(blood)Negative for HIV-1 and HIV-2 antibodies* 3,5

*If using an HIV-1 only rapid test, Negative for HIV-1 antibodies only **This strategy may only be used when a test is available in both oral fluid and blood.

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities Data needs for Strategy 3:
1) Number and percentage of false positive strategy results (i.e. A1+, A2+ in truly uninfected persons) as determined by further clinical evaluation and/or laboratory-based supplemental testing; including false positive rates for test combinations that may have the same antigenic components. 2) Number and percentage of persons referred to medical care based on presumptive positive rapid test results who are in medical care within six months of receiving the results. 3) Number and percentage of specimens with negative rapid tests (A1) that are determined to be false negative results by acute infection screening; and the impact of using riskbased criteria for acute infection screening. 4) Number and percentage of specimens with inconclusive rapid test results for one or more of the following: With false positive A1 results (oral fluid, blood) as determined by laboratory-based supplemental testing With false negative A2 results as determined by laboratory-based supplemental testing 5) Number and percentage of A1 (oral fluid) and A1 (blood) discordant specimens and true infection status of these specimens as determined by laboratory-based supplemental testing. 6) Whether a change in the message a client receives from a counselor, on discordant rapid test results influences the return rate of clients to receive their laboratory test results.

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities
Strategy 4: Three Rapid HIV Tests (A1/A2/A3) Performed in Sequence. (A1, A2, A3 must be Different Rapid Tests. A1 May be Performed on Oral Fluid or Blood; A2 and A3 Must be Performed on Blood.)

A1
[HIV-1 or HIV-1/2 rapid test (Oral Fluid or Blood)]

A1+

A1Negative for HIV-1 and HIV-2 antibodies*3

A2
[HIV-1 or HIV 1/2 rapid test from a different manufacturer (Blood)]

A1+ A2+ Presumptive positive for HIV-1 or HIV-2 antibodies; requires medical follow-up for further evaluation and testing 1,2

A1+ A2A3
[HIV-1 or HIV 1/2 rapid test from a different manufacturer (Blood)]

A1+ A2- A3+ Presumptive positive for HIV-1 or HIV-2 antibodies; requires medical follow-up for further evaluation and testing 1,2,4

A1+ A2- A3Inconclusive rapid test result; requires additional testing 5,6

*If using an HIV-1 only rapid test, Negative for HIV-1 antibodies only

These strategies are not currently recommended for use in POC testing

Proposed Testing Strategies for Point of Care HIV Rapid Testing Facilities Data needs for Strategy 4:
1) Number and percentage of false positive strategy results (i.e. A1+, A2+ in truly uninfected persons) as determined by further clinical evaluation and/or laboratory-based supplemental testing; including false positive rates for test combinations that may have the same antigenic components. 2) Number and percentage of persons referred to medical care based on presumptive positive rapid test results who are actually in medical care within six months of receiving the results. 3) Number and percentage of specimens with negative rapid tests (A1) that are determined to be false negative results by acute infection screening; and the impact of using riskbased criteria for acute infection screening. 4) Number and percentage of specimens with presumptive positive rapid test results that have false negative results on the A2 test as determined by further clinical evaluation. 5) Number and percentage of specimens with inconclusive rapid test results for one or more of the following: With false positive A1 results as determined by laboratory-based supplemental testing With false negative A2 and A3 results as determined by laboratory-based supplemental testing 6) For persons with inconclusive rapid test results (A1+,A2-,A3-), especially if A1 is a more sensitive test for early infection than A2 or A3, data are needed for one or more of the following: Number and percentage of clients that are uninfected Rates of receipt of laboratory test results Whether a change in the message a client receives from a counselor influences client return rates to receive their laboratory test results.

These strategies are not currently recommended for use in POC testing