STAT-PAK HIV1/2,cassette,kit/20

General Description:
The STAT-PAK HIV 1/2 is a single-use immunochromatographic rapid screening test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) in fingerstick whole
blood, venous whole blood, serum or plasma specimens.

Intended Use: The HIV 1/2 STAT-PAK is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV 1 and HIV 2. The HIV 1/2 STAT-PAK is not approved for use to screen blood, plasma, cell or tissue donors.

Technical specifications:
Technology: Rapid immunochromatographic assay.
Format: Lateral flow cassette, 20 tests.
Sample type: Whole blood, serum, plasma.
Sample volume: 20µl (whole blood), 10µl (serum or plasma).
Number of step: 3.
Sensitivity: 99.52%.
Specificity: 100%.
Time to result: 15 mins.

Manufacturer product reference:
Chembio Diagnostic Systems, HIV101.

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Kit content:
·20 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Buffer bottle (3.5ml).
·20 x Disposable 5µl sample loops. (Natech Plastics Inc, USA)
·1 x IFU.

Items required, but not supplied:
Clock, watch or other timing device
Automatic pipettor capable of delivering 5 μL of sample may be used in lieu of the disposable 5 μL sample loop supplied with the kit, for other than fingerstick specimens.
Disposable gloves, sterile gauze (for fingerstick whole blood specimens) Sterile alcohol swab (for fingerstick samples only) and Biohazard disposal container.
Sterile lancet (for fingerstick samples only).
Collection devices for samples other than fingerstick 2 10-6.

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

Weight and Volume:
Estimated weight: 0.8 Kg.
Estimated volume1.44 dm³.

Storage and transportation:
·Between 8 to 30°C.

Packaging and labeling:
Primary packaging: All contents of STAT-PAK HIV 1/2, cassette, for 20 tests.
Secondary packaging: One kit STAT-PAK HIV 1/2, cassette, 20 tests.

General recommendations:
1.Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
2.Do not use any other specimen than those specified.
3.Apply standard biosafety precautions when handling and disposing of potentially infectious material.

Useful links:
WHO list of prequalified in vitro diagnostic products:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/