Table 1.
Analytical specificity and sensitivity of the DBS eluate testing for markers of HBV, HCV and HIV infections compared to serum analyses
|
Parameters |
Serum |
DBS eluates |
Specificity (%)/ 95% CIa) |
Sensitivity (%)/ 95% CIa) |
||
|---|---|---|---|---|---|---|
| n. d. (N) | pos. (N) | n. d. (N) | pos. (N) | |||
|
HBV |
|
|
|
|
|
|
| HBsAg |
159 |
140 |
161 |
138 |
100/97.7 – 100 |
98.6/94.9 – 99.8 |
| Anti-HBc |
101 |
204 |
129b) |
176b) |
100/97.2 – 100 |
86.3/83.0 – 91.8b) |
| 107c) |
198c) |
97.1/93.9 – 99.0c) |
||||
| Anti-HBs |
153 |
157 |
162b) |
148b) |
100/97.6 – 100 |
94.3/90.0 – 97.5b) |
| 157c) |
153c) |
97.5/93.8 – 99.3c) |
||||
| HBV DNA |
50 |
100 |
107 |
93 |
100/96.1 – 100 |
93.0/92.9 – 93.1 |
|
HCV |
|
|
|
|
|
|
| Anti-HCV |
160 |
179 |
164 |
175 |
100/97.7 – 100 |
97.8/96.0 – 100 |
| HCV RNA |
50 |
100 |
50 |
100 |
100/96.1 – 100 |
100/98.0 – 100 |
|
HIV |
|
|
|
|
|
|
| HIV-1-p24/anti-HIV 1/2 | 97 | 112 | 97 | 112 | 100/96.3 – 100 | 100/96.8 – 100 |
The results of the serum analyses served as reference for the calculation of the analytical performance characteristics of the DBS testing. — n. d.: not detectable; pos.: positive.
a) 95% confidence interval calculated according to Clopper and Paerson [50]. b) Calculated with inclusion of the results obtained from HIV infected individuals. c) Calculated without the results recorded from HIV infected individuals.