Mylan HIV Self-Test, kit/1T

General description:
The Mylan HIV Self-Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the detection of antibodies to HIV-1 and HIV-2 in whole blood. The Mylan HIV Self-Test is intended to be used by untrained lay users in a private setting as a self-test to aid in the diagnosis of infection with HIV-1 and HIV-2 from samples of fresh, whole blood obtained through a finger stick blood collection technique.

Technical specifications:
Sensitivity: 99.8%
Specificity: 99.8%
Time to result: 15 minutes. Do not wait more than 20 minutes.
Specimen type: Whole blood
Sample volume: 10ul

Manufacturer product reference: Atomo Diagnostics Pty Ltd, ARST001-03

Items supplied with:
·Mylan HIV Self-Test device (in foil packet with a desiccant), 1
·Bottle of Test Fluid (Diluent) 2ml, 1
·Alcohol wipe, 1
·Disposable bag, 1
·Instructions for Use (IFU), 1

Items required, but not supplied:
Timer, box of tissues or other clean, absorbent material

Shelf life:
18 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.080 kg
Estimated volume: 0.057 m³

Storage and transportation condition:
Between 2 to 30 °C. Protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Mylan HIV Self-Test for 1 test
Secondary packaging: One kit Mylan HIV Self-Test, 1 test

General recommendations:
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
·Do not use if the test device pouch is broken.
·Do not use if you:
vhave a bleeding disorder.
vare on Antiretroviral Therapy (ART).
·Blood can transmit infectious diseases. Clean up spills.

Useful links:
WHO list of prequalified in vitro diagnostic products: