Table 1 Comparison of pool and individual Abbott RealTime HIV-1 viral load testing results for 447 specimens re-tested individually from all pools with a result of HIV-1 detected, conducted as part of method validation prior to scale-up of pooled testing for all routine specimens. Following this method validation, ≥ 40 copies/ml for a pooled result was chosen as the cut-off for re-testing each specimen in a positive pool; this was chosen to improve testing efficiency while minimizing the chance for misclassification of an unsuppressed specimen as suppressed.

From: Implementation of pooled testing to increase access to routine viral load monitoring for people living with HIV on antiretroviral therapy

Pool result (copies/mL)

Individual result (copies/mL)

Total

Number (%) that would be misclassified as suppressed*

Undetectable

Suppressed, detectable

Unsuppressed

0

< 40

40–119

120–199

200–1000

1001–5000

5001–10,000

10,001-100,000

> 100,000

< 40

149

28

27

2

1

    

207

0/207

0%

40–119

46

7

7

7

5

    

72

0/72

0%

120–199

10

2

2

2

5

    

21

0/21

0%

200–1000

19

8

 

2

8

5

   

42

5/42

12%

1001–5000

17

5

2

 

1

6

3

2

 

36

n/a

5001–10,000

7

 

1

 

2

 

2

3

 

15

10,001-100,000

19

4

1

    

7

5

36

> 100,000

9

1

2

     

6

18

Total

276

55

42

13

22

11

5

12

11

447

  
  1. *Specimens with concentrations > 1,000 copies/mL (unsuppressed) that would be misclassified as suppressed (< 1,000 copies/mL) if no re-testing of individual specimens (from positive pools) was performed.