HIV 1/2/O Rapid Test Cassette

What is this product?

HIV 1/2 test – is a rapid test for the diagnosis of Human Immunodeficiency Virus to detect antibodies to HIV type 1, type 2 and Subtype O qualitatively in whole blood, serum or plasma to aid in the diagnosis of HIV infection. It is intended for professional in vitro diagnostic use only.

What should I know about HIV?

• HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS)
• The virion is surrounded by a lipid envelope that is derived from the 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-1 consists of Subtype M and Subtype O. Highly divergent strains of HIV-1 were first recognized in 1990 and grouped provisionally as Subtype O as this variation has similar glycoprotein markers to HIV-1 but a slight variation to the protein marker. Although rarely compared to HIV-1 and HIV-2, infections caused by Subtype O have so far been identified in Africa (Cameroon), France and Germany. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.
• HIV-1, HIV-2, and Subtype O all elicit immune responses.
• 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 the differences in their biological characters, serological activities and genome sequences, HIV-1, HIV-2, and Subtype O show strong antigenic cross-reactivity.
• Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.
• The HIV 1/2/O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type 1, type 2, and/or Subtype O in whole blood, serum or plasma specimen.

How this test works?

The HIV 1/2/O Rapid Test Cassette(Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens in the test line regions, T1 and T2. The T1 test line is pre-coated with HIV-1 and Subtype O antigen and the T2 test line is precoated with HIV-2 antigen. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen coated particles in the test strip. 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.

What should I remember using this product?

• The test contains HIV type 1, type 2, and Subtype O recombinant antigens coated particles and HIV type 1, type 2, and Subtype O recombinant antigens coated on the membrane.
• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or test cassettes are handled.
• Do not use test if pouch is damaged.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• The used test should be discarded according to local regulations.

What should I know about kit storageand stability?

• Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C).
• The test is stable through the expiration date printed on the sealed pouch.The test must remain in the sealed pouch until use.
• DO NOT FREEZE the kit.
• Do not use after the expiration date.
• For long term storage, specimens should be kept below -20°C.
• Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection.
• Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
• Humidity and temperature can adversely affect results.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• The HIV 1/2/O Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
• Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days.
• If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

How should I use this kit?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer, see illustration below.

For Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 2 drops of buffer (approximately 80μL), and start the timer. See illustration below.

Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

• If the specimen contains antibodies to HIV-1 and/or Subtype O, or HIV-2, one colored line will appear in the test line region.
• If the specimen contains antibodies to HIV-1 and/or Subtype O, and HIV-2, two colored lines will appear in the test line region. Both indicate a positive result.
• If the specimen does not contain HIV-1, Subtype O, and/or HIV-2 antibodies, no colored line will appear in the test line region indicating a negative result.

POSITIVE:Two or three distinct colored lines appear. One line should always appear in the control line region, and another one or two apparent colored line(s) should appear in the test line region(s) (T1 and/or T2).

*NOTE: The intensity of the color in the test line region (T1 and T2) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test line region (T1 and/or T2) should be considered positive.

NEGATIVE: One colored line appears in the control region. No apparent colored lines appear in the test line regions (T1 and T2).

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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

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.

A procedural control is included in the test. A colored line appearing in the control line region is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.