This test is a single use, rapid device intended for qualitative detection of antibodies to Human

Immunodeficiency Viruses or HIV(1/2) in Saliva Samples. It is intended for use in medical institution

as an aid for the diagnosis and management of patients related to infection with HIV infection

Components

1. Alluminium Pouch 1 Pouch (Each pouch contains one test strip and

one desiccant)

2. Saliva Sample Buffer 1 bottle (0.8ml per bottle)

3. Saliva Sample Collection Swabs 1 bag (1 per bag)

4. Package Insert 1 sheet

Materials used but not provided

1. 15-30 minute timer or watch

2. Disposable gloves

3. Biohazard disposal container

sensitivity was 99.28% (548/552)

specificity was 99.48% (759/763).

Accuracy of 99.32% based on internal Quality Control standards.