Intended Use

The HIV 1/2 Rapid Test Cassette (Serum/Plasma/Whole blood) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1 and type 2 in serum , plasma or whole blood.

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virus 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 or plasma 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 the differences in their biological characteristics, serological activities and genome sequences,HIV1 and HIV2 show strong antigenic cross-reactivity. Most HIV 2 positive sera can be identified by using HIV 1 based serological tests.The HIV 1/2 Rapid Test Cassette (Serum/Plasma/Whole blood) is a rapid test to qualitatively detect the presence of antibodies to HIV-1 and HIV- 2 in serum, plasma or whole blood specimen. The test utilizes Gold conjugate and multiple recombinant HIV proteins to selectively detect antibodies to the HIV 1/2 in serum , plasma or whole blood.

The HIV 1/2 Rapid Test Cassette (Serum/Plasma/Whole blood) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1/2 in serum, plasma or whole blood. The membrane is pre-coated with recombinant HIV antigens including gp41 and gp36 recombinant antigen. And the conjugate pad is treated with gold particles which are conjugated with gp41and gp36 recombinant antigen. During testing, the serum, plasma or whole blood specimen reacts with HIV antigen coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region. If the specimen contains antibodies to HIV 1, HIV 2, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain HIV 1, HIV 2 antibodies, a colored line will not appear in the test line region,indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Specification

Read time	10-20 min
Shelf life	36 months
Store temperature	2-30℃
Operation temperature	15-30℃
Sensitivity	99.9%
Specificity	99.3%
Accuracy	99.5%

Why To Test

1.What is HIV ?

Human Immunodeficiency Virus (HIV) is a retrovirus that primarily attacks the immune system, specifically CD4+ T lymphocytes, leading to progressive deterioration of immune function.If untreated, HIV infection can advance to Acquired Immunodeficiency Syndrome (AIDS), the final stage characterized by severe opportunistic infections and cancers.HIV is categorized into two types: HIV-1 (most common globally) and HIV-2 (less prevalent and slower progressing). The virus is enveloped and has a single-stranded RNA genome

2.How does HIV spread?

HIV transmission requires direct contact with certain body fluids containing high viral loads.

The primary routes are:

Sexual Contact: Unprotected vaginal, anal, or oral sex with an infected person.
Blood Transmission: Sharing contaminated needles/syringes (e.g., drug use), transfusion with infected blood products, or exposure to unsterilized medical equipment.
Mother-to-Child Transmission: During pregnancy, childbirth, or breastfeeding.
HIV cannot be spread via casual contact (e.g., hugging, sharing utensils, mosquito bites, or air droplets).

3.What are the symptoms of HIV and severe HIV?

Acute HIV Infection (2–4 weeks post-exposure)Flu-like symptoms such as fever, fatigue, rash, sore throat, and swollen lymph nodes.Symptoms are mild and often resolve spontaneously, but the virus remains highly contagious.Clinical Latency Stage (Asymptomatic Phase)May last 6–10 years or longerwithout obvious symptoms.The virus continues to replicate, gradually weakening the immune system.Severe HIV (AIDS Stage)Marked by a significant drop in CD4+ cell count (<200 cells/μL) and severe opportunistic illnesses.

Common manifestations include:

Infections: Tuberculosis, pneumonia, meningitis, and severe fungal infections.
Cancers: Kaposi's sarcoma, lymphoma.
Neurological symptoms: Memory loss, dementia, and motor coordination deficits.

Test Method

POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.