ASPEN HIV 1/2 Test Kit

Aspen Laboratories Pvt Ltd, India

Aims to provide quality products and the highest level of service for diagnostics segments. Through innovation and total commitment Aspen strive to create value for its customers

Through a combination of sustained, organic growth and an acquisition-led strategy, the company has assembled an impressive product portfolio and achieved the highest standards of excellence in marketing diagnostic products in Indian market.

ASPEN HIV 1/2 Test Kit

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

Packaging included: 1 Aspen HIV Test Kit, 1 diluent, 1 twist lancet, 1 alcohol swab, 1 pipette

Directions For Use:

Add 1 drop (25 µl) of Whole Blood to specimen well of test device using dropper/pipette.
Then add 2 drop of buffer (40 µl )
Read results in 10 minutes (Do not interpret the result after 20 minutes)

Interpretation of Results

POSITIVE:* Two or three distinct colored lines appear. One line should always appear in the
control line region (C), 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 (C). 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.

Clinical Sensitivity, Specificity and Accuracy

The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) was evaluated a blood as in in-house clinical study and the in 2 specimens and an HIV Performance Panel that was purchased from a commercial source.

The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) was compared to leading commercial ELISA HIV test and /or Western Blot.

Clinical Sensitivity: 100%

Specificity: 99.8%