TABLE 3.

Reproducibility of the N3M-PCR assay for detecting HIV-1 infection among infants in different age groups

HIV-1 gene region(s)	Results for infants ageda:
	48 h (n = 7)				1-2 mo (n = 10)				3-6 mo (n = 15)
	1st test	2nd test	3rd test	Reproducibility (%)	1st test	2nd test	3rd test	Reproducibility (%)	1st test	2nd test	3rd test	Reproducibility (%)
env	7	7	7	100	10	10	10	100	14	14	15	95.4
gag	7	6	7	95.2	10	9	10	96.7	15	15	13	95.6
pol	7	7	7	100	10	9	9	93.3	15	12	13	88.9
Three regions combinedb	7	7	7	100	10	9	10	96.7	15	15	15	100

^aValues in the 1st test, 2nd test, and 3rd test columns indicate the numbers of samples with identical results. The reproducibility values are derived from the average number of samples with identical results for three repeated testings divided by the number of samples used for reproducibility testing.

^bCombined results from all three regions were interpreted as follows: (i) if more than two regions of the pol, gag, and env genes were positive, the samples were determined to be HIV-1 positive; (ii) if only one region was positive, the results were reported as indeterminate for HIV-1; moreover, HIV-1 DNA samples determined to be indeterminate or positive were retested by the N3M-PCR assay; (iii) if none of the three regions was amplified, the samples were considered HIV-1 negative.