HBsAg and HCV and HIV Combo Rapid Test

Intended Use

HBsAg and HCV and HIV Combo Rapid Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of HBsAg antigen, and/or antibodies to HCV, HIV 1/HIV-2 in human serum or plasma specimens. HBsAg and HCV and HIV Combo Rapid Test is intended for use as an aid in the diagnosis of HBV, HCV and HIV infection.

Introduction

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibodies to HCV are found in over 80% of patients with well-documented non-A, non-B hepatitis. HCV is predominantly a blood-borne virus, with very low risk of sexual or vertical transmission. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to first generation HCV EIAs using single recombinant antigens, new serologic tests include multiple antigens using recombinant protein and/or synthetic peptides to avoid nonspecific cross-reactivity and to increase sensitivity.

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in the lipid envelope of this small DNA virus. During the replicative phase of the virus, this surface antigen is produced in excess and is detectable in the blood of the infected. The incubation period of HBV is 6 weeks to 6 months.

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and HIV-2 elicit immune response. Detection of HIV antibodies in serum, plasma or whole blood is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite differences in their biological characters, serological activities and genome sequences, HIV-1 and HIV-2 show strong antigenic cross-reactivity. Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.

HBV and HIV are bloodborne viruses transmitted primarily through sexual contact and injection-drug use. Because of these shared modes of transmission, a high proportion of adults at risk for HIV infection are also at risk for HBV infection. People with HIV who become infected with HBV are at increased risk for liver-related morbidity and mortality. As HCV is a bloodborne virus transmitted through direct contact with the blood of an infected person, coinfection with HIV and HCV is common (62%–80%) among injection-drug users who have HIV.

Materials

● Combo test devices

● Package insert

● Disposable pipettes

Test Procedure

Bring tests, specimens 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 device with patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 75 µL) into each specimen well (S) of the device, then start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

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 the result after 20 minutes.

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