Introduction
BioTracer™ HSV-2 Rapid Test is a Point-of-Care-Testing for the detection of Herpes Simplex Virus type 2 (HSV-2) antibodies.
• Herpes Simplex Virus type 2 Antibody Test
• Immunochromatography based one step in vitro diagnostics test
• No instrument needed
• Sensitivity : 97.18% , Specificity : 97.6%
• Specimen : Serum , Plasma or Whole Blood
• Reading Time : 10 min
• Simple and easy to use Lateral-flow type test compared to Flow-through type test
Performance Characteristics
A study was performed using 421 positive and negative serum specimens. Each specimen was assayed with the BioTracer™ HSV-2 Rapid Test and a FDA approved ELISA kit.
BioTracer™ HSV-2 Rapid Test
Total
Positive
Negative
HerpeSelect® 2 ELISA IgG
Positive
207
6
213
Negative
5
203
208
Total
212
209
421
The sensitivity is 97.18 %( 207 / 213) and specificity is 97.6 %( 203 / 208)
Test Procedure
? A positive result will not change once it has been established at 10 minutes, however in order to prevent any incorrect results, the test results should not be interpreted after 20 minutes.
Specification
Cat. No.
Product
Type
Pack Size
Specimen
Shelf Life
11219
HSV-2
Card
10T/Kit
Serum/Plasma/Whole blood
18 M
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