Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings & populations

Table 3 Kappa statistics and positive and negative samples detected by rapid tests using saliva (3) and whole blood (1) samples compared to results obtained using respective serum samples by enzyme immunoassay ETI-MAK-4®^, according to the characteristics of the population under analysis

Profile/Manufactory – Biological specimen	TP	FN	TN	FP	K
Group I
Vikia HBsAg® - SALIVA	6	76	101	2	5.92 % (0.00–21.8)
Imuno-Rápido HBsA® - SALIVA	33	49	101	2	40.68 % (26.82–54.54)
Teste rápido HBsAg®- SALIVA	2	80	101	2	0.55 % (0.00–16.61)
Vikia HBsAg® - WHOLE BLOOD	18	10	80	0	72.73 % (56.63–88.83)
Group II
Vikia HBsAg® - SALIVA	0	2	153	5	^a
Imuno-Rápido HBsA® - SALIVA	1	1	155	3	32.2 % (0.00– 97.8)
Teste rápido HBsAg® - SALIVA	0	2	158	0	^a
Vikia HBsAg® - WHOLE BLOOD	0	3	763	1	^a
Group III
Vikia HBsAg® - SALIVA	0	4	153	0	^a
Imuno-Rápido HBsA® - SALIVA	0	4	149	4	^a
Teste rápido HBsAg® - SALIVA	0	4	150	3	^a
Vikia HBsAg® - WHOLE BLOOD	4	2	387	0	79.75 % (51.76–100.00)
Overall
Vikia HBsAg® - SALIVA	6	82	407	7	7.72 % (0,00–25,11)
Imuno-Rápido HBsA® - SALIVA	34	54	405	9	45.65 % (33.1–58.2)
Teste rápido HBsAg® - SALIVA	2	86	409	5	1.67 % (0.00–19.95)
Vikia HBsAg® - WHOLE BLOOD	22	15	1230	1	72.72 % (59.44–86.00)

Legend: TP True positive, FN False negative, TN True negative, FP False positive, k kappa statistics, n number of observations (biological samples), CI confidence interval
^anot amenable to calculation

ISSN: 1471-2334