TABLE 3.
Analytical sensitivity (50% and 95% detection limits) of NAT systems on (dilutions of) the Eurohep HBV DNA genotype A2 standard, Ultrio HBV NAT–yield samples, and HBsAg-positive and Ultrio initially nonreactive samples as determined by parallel line probit analysis
LOD (copies/mL)
|
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---|---|---|---|---|---|---|---|---|---|
Number of
|
Ultrio
|
Ultrio Plus
|
TaqScreen
|
||||||
Samples | Dilutions | Replicates | 50% (CI) | 95% (CI) | 50% (CI) | 95% (CI) | 50% (CI) | 95% (CI) | |
Eurohep standard | 1 | 10 | 24 | 9.3 (6.4–13.7) | 90.2 (55.9–165) | 4.5 (3.0–6.6) | 43.1 (26.8–77.9) | 2.2 (1.3–3.9) | 21.4 (11.7–43.8) |
HBV NAT yields | 107 | 3 | 6 | 10.6 (9.2–12.3) | 120 (94.8–157) | 4.3 (3.7–5.0) | 48.7 (39.3–62.2) | 4.6 (3.6–5.9) | 51.7 (38.3–71.7) |
HBsAg yields | 32 | 1* | 12 | 375 (156–1267) | 1248 (564–3974) | 4.0 (2.8–5.6) | 34.8 (26.8–139) | 2.5 (1.4–4.1) | 37.9 (20.6–89.2) |
Eight samples that were 100% reactive in Ultrio Plus and TaqScreen were tested in 1:8 dilution to compare percentage response in these assays with that on the undiluted samples in the Ultrio assay.