Berkeleyhealth Easy Check Hiv Test Rapid Self-Test 1 Pc

Product Description:

• A rapid test for the diagnosis of Human Immunodeficiency Virus (HIV) to detect antibodies to HIV Type 1 and HIV Type 2 qualitatively in human whole blood, serum, or plasma. For professional in vitro diagnostic use only.


• The HIV 1/2 Rapid Test, HIV Antibody Test, HIV Screening Test, and Professional HIV Diagnostic Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood, serum, or plasma to aid in the diagnosis of HIV infection.


• HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope derived from the host cell membrane. Several viral glycoproteins are present on the envelope. Each virus contains two copies of positive-sense genomic RNA.


• HIV-1 has been isolated from patients with AIDS and AIDS-related complex, as well as from healthy individuals with a 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 an immune response.


• Detection of HIV antibodies in serum or plasma is one of the most efficient and commonly used methods to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV.


• Despite differences in biological characteristics, serological activities, and genome sequences, HIV-1 and HIV-2 exhibit strong antigenic cross-reactivity.


• Most HIV-2 positive sera can be identified using HIV-1 based serological tests.


• The HIV 1/2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that qualitatively detects the presence of antibodies to HIV-1 and/or HIV-2 in whole blood, serum, or plasma specimens.


• The test utilizes latex conjugates and multiple recombinant HIV proteins to selectively detect HIV-1 and HIV-2 antibodies in human specimens.

Product Features:

• The HIV 1/2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of antibodies to HIV-1 and HIV-2 in whole blood, serum, or plasma.


• The membrane is pre-coated with recombinant HIV antigens.


• During testing, the whole blood, serum, or plasma specimen reacts with HIV antigen-coated particles in the test cassette.


• The mixture migrates chromatographically by capillary action and reacts with recombinant HIV antigens on the membrane in the test line region.


• If the specimen contains antibodies to HIV-1 and/or HIV-2, a colored line will appear in the test line region, indicating a positive result.


• If the specimen does not contain antibodies to HIV-1 and/or HIV-2, no colored line will 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, confirming that sufficient specimen volume has been added and proper membrane wicking has occurred.


• This rapid HIV antibody detection test provides a reliable method for HIV screening and professional diagnostic applications.

How to use:

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


• 1. Remove the test Cassette from the sealed pouch and use it as soon as possible.


• 2. 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 40 μL),and start the timer, see illustration below. For Venipuncture Whole Bloodspecimen: 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. For Fingerstick Whole Bloodspecimen: To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test Cassette, then add 2 drops of buffer (approximately 80 μL) and start the timer. See illustration below. To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50μL) to fall into the specimen area of test Cassette, then add 2 drops of buffer (approximately 80 μL) and start the timer. See illustration below.


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

Caution & Warnings:

• Read these instructions carefully before performing the test. The test is reliable only if all the instructions are followed correctly.


• Keep the test out of the reach of children.


• Do not use the test after the expiration date or if the package has been damaged.


• Follow the procedure exactly, using only the specified quantities of blood and diluent


• Store the test components at a temperature between +4°C and +30°C. Do not freeze.


• Use the test and lancing device only once.


• The test is for external use only. Do not follow.


• In vitro diagnostic device for individual use.


• It is not recommended for people who take anti-coagulant medications (blood thinners) or for people suffering from hemophilia.


• After using. Please dispose of all components according to your local waste disposal laws. Ask your pharmacist for advice.

Ingredients:

• Materials provided:


• Test cassettes


• Droppers


• Buffer


• Package insert Materials required but not provided;


• Specimen collection containers


• Centrifuge


• Timer