CDIA™ Hepatitis A Virus IgM Test Cassette - Creative Diagnostics

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CDIATM Hepatitis A Virus IgM Test Cassette (DTS586)

Intended Use

The HAV IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatit is A virus (HAV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive specimen with the HAV IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
  • Serum
  • Cassette
  • 1:04

Product Introduction

General Description
HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact. The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients.
Principle Of The Test
The HAV IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing HAV antigens conjugated with colloid gold (HAV conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with monoclonal anti-human IgM antibody, and the C band is pre-coated with goat anti-rabbit IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. Anti-HAV IgM if present in the specimen will bind to the HAV conjugates. The
immunocomplex is then captured on the membrane by the pre-coated anti-human IgM, forming a burgundy colored T band, indicating a HAV IgM positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on the T band. therwise, the test result is invalid and the specimen must be retested with another device.

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