BioKit HSV-2 (Herpes) Rapid Test
For Professional Use Only
MUST PROVIDE MEDICAL LICENSE
INTENDED USE
The biokit HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative
determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of
circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a
result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in
Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous
infection with HSV-2 and may be of value in determination of previous immunological
experience and to aid in the diagnosis of HSV associated disease. This assay will not
differentiate whether infection is currently in a latent or active state.
biokitHSV-2 Rapid test Kit Feature
o Type-specific serology test recommended by experts
o Finger-stick blood or serum specimens
o 7-10 minute test time
o Easy to use two-reagent system
o Built-in controls
o Sensitivity - 96% (compared to viral culture and Western blot)
o Specificity - 98% (compared to viral culture and Western blot)
o Detects seroconversion in as little as two weeks
o Designed for use in Physician's Offices, Laboratories, Family Practice and STD clinics
Product Information
o Packaging - 20 tests per kit
o Product Number - 3000-28001
o CPT Code - 86696
PROCEDURE
1. Label the device with the patient's
name or identification number and
peel back the protective
label, revealing the round TEST
WINDOW.
2. Place the empty plastic Vial 1 into a rack.
Pour contents of the Sample Diluent vial into
Vial 1 and discard the empty Sample Diluent vial.
3. Take the patient's blood sample,
using the capillary pipet provided.
When using serum (50µl)
dispense directly into vial.
4. Place the blood-filled capillary
tube into Vial 1 which contains the
sample diluent buffer.
5. Fit the pre-filter tip onto Vial 1,
ensuring that the tip clicks securely
into the vial. Gently mix the blood
sample and diluent by inverting
Vial 1 several times.
6. Keeping the pre-filter tip on the vial,
squeeze all the sample/diluent mixture
onto the TEST WINDOW, by
squeezing the middle of the vial.
7. Allow the sample diluent mixture to be
absorbed into the test device. Mix the
developing reagent by inverting
several times. Remove lid,
dispense into the TEST WINDOW.
8. Read and record the results
of the test.
ABOUT
FACT: 50-60 million people are infected with genital herpes (HSV-2) today in the United States.
FACT: 90% of them don't know they have HSV-2.
Who's at Risk?
o Any patient at risk for sexually transmitted diseases (STD) including HIV.
o People who have a history of symptoms suggestive of genital herpes.
About Genital Herpes
Genital herpes is a sexually transmitted disease caused by the herpes simplex viruses type 1 (HSV-1)
and type 2 (HSV-2). Over 80% of recurring genital herpes is due to HSV-2. Type-specific
serology has been shown to be the best way to detect persons with subclinical or recurring genital herpes.
-Quantity: 20 Tests
-Moderately Complex
BioKit HSV-2 (Herpes) Rapid Test