Table 1.
Laboratory quality control result | Performance % (95% confidence interval) | ||||||
---|---|---|---|---|---|---|---|
Rapid test result (community) |
Negative | Positive | Total (%) | Sensitivity | Specificity | Positive Predictive Value |
Negative Predictive Value |
| |||||||
Parallel testing a | |||||||
Negative | 2095 | 3 | 2098 | 99.6(98.9-99.9) | 100.0(99.7–100.0) | 99.9(99.3–100.0) | 99.9(99.6–100.0) |
Positive | 1 | 812 | 813 | ||||
Serial testing b | |||||||
Negative | 2095 | 4 | 2099 | 99.5(98.7-99.9) | 100.0(99.7–00.0) | 99.9(99.3–100.0) | 99.8(99.5–99.9) |
Positive | 1 | 811 | 812 | ||||
Uni-Gold™ alone | |||||||
Negative | 2089 | 8 | 2097 | 99.0(98.1-99.6) | 99.7(99.3–99.9) | 99.1(98.2–99.7) | 99.6(99.2-99.8) |
Positive | 7 | 807 | 814 | ||||
Determine™ alone | |||||||
Negative | 2043 | 3 | 2046 | 99.6(98.9-99.9) | 97.5(96.7–8.1) | 94.5(92.8–96.0) | 99.9( 99.6–100.0) |
Positive | 47 | 812 | 859 | ||||
Inconclusive | 6 | 0 | 6 | ||||
Total | 2096 | 815 | 2911 |
Parallel testing strategy: actual strategy, tests used Determine™, Uni-Gold™ and SD Bioline, result negative defined as non-reactive for at least two of the three rapid tests; result positive defined as reactive for at least two of the threerapid tests
Serial testing strategy: theoretical strategy, tests used Determine™, Uni-Gold™ and SD Bioline tests, result negative defined as non-reactive for Determine™ alone or nonreactive for both Uni-Gold™ and SD Bioline; result positive defined as reactive for Determine™ and Uni-Gold™ or reactive for Determine™ and SD Bioline