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. Author manuscript; available in PMC: 2013 Aug 1.
Published in final edited form as: J Clin Virol. 2012 May 20;54(4):355–358. doi: 10.1016/j.jcv.2012.04.004

Table 1.

Overall agreement between IsoAmp® HSV Assay and ELVIS®: Before and after discrepant analysis by bidirectional sequencing, all prospective specimens

Before discrepant analysis After discrepant analysis
Overall ELVIS Overall ELVIS
POS NEG Total POS NEG Total
IsoAmp POS 309 49 i 358 IsoAmp POS 351 7 358
NEG 11 ii 593 604 NEG 5 599 604
Total 320 642 962 Total 356 606 962
Value (%) 95% CI Value (%) 95% CI
Positive agreement 96.6 94.0 – 98.1 Positive agreement 98.6 96.8 – 99.4
Negative agreement 92.4 90.1 – 94.2 Negative agreement 98.8 97.6 – 99.4
PPV 86.3 82.4 – 89.5 PPV 98.0 96.0 – 99.0
NPV 98.2 96.8 – 99.0 NPV 99.2 98.1 – 99.6
Prevalence 33.3 30.4 – 36.3 Prevalence 37.0 34.0 – 40.1
Total Agreement 93.8 Total Agreement 98.8

POS = positive (HSV detected); NEG = negative (HSV not detected); PPV = positive predictive value; NPV = negative predictive value; CI = confidence interval

i

49 samples were tested using bidirectional sequencing analysis. Sequence analysis detected HSV target in 42 of the 49 discordant samples [18 HSV-1 and 24 HSV-2] identified as HSV Positive by the IsoAmp® HSV Assay. Sequence analysis did not detect HSV in seven (7) of the discordant samples.

ii

Eleven (11) samples were tested using bidirectional sequencing analysis. Sequence analysis did not detect HSV target in six (6) of the 11 samples identified as HSV Negative by the IsoAmp® HSV Assay. Sequence analysis did detect HSV in five (5) samples [3 HSV-1 and 2 HSV-2]