TABLE 4.
Performance evaluation of the DRW and Determine HBsAg rapid tests in China and Guinea using EIA as the gold standarda
| Country | Test | Sensitivity
|
Specificity
|
||
|---|---|---|---|---|---|
| No. positive/true positivesb | % (95% CI) | No. negative/true negativesc | % (95% CI) | ||
| China | DRW | 185/186 | 99.46 (98.41-100) | 481/485 | 99.18 (98.37-99.98) |
| Determine | 184/186 | 98.92 (97.44-100) | 485/485 | 100 (100-100) | |
| Guinea | DRW | 174/180 | 96.66 (94.04-99.29) | 399/399 | 100 (100-100) |
| Determine | 170/180 | 94.44 (91.10-97.79) | 399/399 | 100 (100-100) | |
The sensitivities and specificities of both tests were calculated relative to the results of the Hepanostika HBsAg Ultra EIA (BioMerieux, Lyon, France).
Number of samples positive by the DRW or Determine HBsAg rapid test/number of samples positive by two EIAs. The 186 samples from China comprise 15 EIA-positive samples from 500 randomly selected blood donor samples and 171 HBsAg-positive clinical samples. The 180 samples from Guinea comprise 92 EIA-positive samples from 491 randomly selected blood donor samples and 88 stored HBsAg-positive samples.
Number of samples negative by the DRW or Determine HBsAg rapid test/number of samples negative by two EIAs.