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Table 1 Results of duplicate sample tests in testing and external quality control laboratories

From: Viral load testing in a resource-limited setting: quality control is critical

 

Lab 1 vs. Lab 2

2006

Lab 1 vs. Lab 3

2006

Lab 2 vs. Lab 4 vs. Lab 5*

2007

Number of sample sets

21

29

10

Range of log VL results reported

ND-6.1

ND-5.7

ND-4.6

N (%) of duplicate samples with difference in log VL result >1.0

13 (62%)

14 (48%)

1 (10%)

Mean (range) absolute difference in log VL result

1.1 (0.0-2.8)

1.2 (0.0-3.1)

0.2 (0.0-1.2)

Limits of agreement of tests (log VL result)

-4.777 to 0.801

-3.089 to 3.246

-0.796 to 0.848

False negatives: N (%) VL undetectable in testing lab but >1000 copies/mL in QC laboratory

[same comparison but >5000 copies/mL]

0

5 (17%)

[5 (17%)]

0

False positives: N (%) >1000 copies/mL in testing lab but undetectable in QC laboratory

[same comparison but >5000 copies/mL]

6 (29%)

[1 (5%)]

8 (28%)

[5 (17%)]

0

  1. *Samples were sent in triplicate to Lab 2, Lab 4 and Lab 5. VL = Viral load. QC = Quality control. ND = Not detectable.
  2. †Bland Altman comparison [10]