【INTENDED USE】
The HSV 1/2 Rapid Test is a rapid visual immunoassay for the qualitative presumptive detection of HSV-1 and HSV-2 IgM & IgG antibodies in human whole blood, serum or plasma to determine if someone is infected by herpes simplex virus.
【INTRODUCTION】
HSV is an envelop, DNA-comtaining virus morphologically similar to the other members of the genus Herpesviridae.Two antigenically distinct types are recognized, designated type 1 and type 2. HSV type 1 and 2 are frequently implicated in superficial infections of the oral cavity, the skin, the eye and the genitalia, Infections of the central nervous system (meningoencephalitis)and severe generalized infection in the neonate of immunocompromised patient are also seen, though more rarely. After the primary infection been resolved, the virus may exist in a latent form in nervous tissue, from where it may re-emerge, under certain conditions, to cause a recurrence of the symptoms. Although Herpes Simplex Virus type 1 and type 2 have many things in common, the HSV type 1 is the cause of most orofacial herpes and Hsv encephalitis; type 2 is the primary cause of initial and recurrent genital herpes and neonatal HSV. In other word, genital herpes is most frequently caused by HSV-2 where it establishes latency in dorsal nerve root ganglia. Intermittent reactivation of virus occurs in most people who are infected with HSV-2. These reactivations cause genital lesions and the viral shedding on mucosal areas. Genital HSV infection may be sub-clinical, which means that a significant number of patients may not realize that they are infected and may unknowingly transmit the virus to partners. Numerous studies report that,while infection with HSV-2 frequently results in periods of overt disease (expressing "typical”or"atypical”symptoms) followed by periods of viral latency with no overt disease, the disease does not self-cure. Neither can it be cured through medical intervention.
【CONTENTS】
• Rapid Test Cassette.
• Dropper.
• Buffer.
• Instruction for use
【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【SAMPLE COLLECTION AND STORAGE】 ·
The HSV1/2 IgG/IgM Rapid Test is intended for use with human whole blood, serum or plasma specimens only. ·Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis. ·Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. ·Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens. ·If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents. ·Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to each specimen well (S) of the cassette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes.Do not interpret after 20 minutes.
【INTERPRETATION OF RESULTS】
Positive (+) :
IgG Positive: Both IgG test region (IgG) and control region appear color line.
IgM Positive: Both IgM test region (IgM) and control region appear color line.
IgG/IgM Positive: Both test region (IgG and IgM) and control region appear color line.
Negative (-) :
Only one color line appears on the control region (C).
Invalid:
No visible line at all, or there is a visible line only in the test regionandnotinthe control region. Repeat with a new test kit.
【TEST LIMITATIONS】
1. The HSV 1/2 IgG/IgM Rapid Test is for professional in vitrodiagnosticuse,and should be used for the qualitative detection of HSVonly.
2. There is no meaning attributed to line color intensity or width. For positivecases, more advanced quantitative testing method should be usedbeforeanyclinical conclusion can be made.
3. If it is the first time for the patient to be infected, within 5 days, thereisnodetectable specific antibody in his/her serum. In this windowperiod, thetestwillgive a negative result when testing with this test cassette.
4. The HSV 1/2 antibody of the mother will appear in the serumsampleofaone-year old child, therefore it is improper to use independentlythetest resultof a one-year old baby as the clinical proof either for its historyof infectionorfor its immunization status.
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