ONE STEP Anti-HIV (1&2) with acc, kit/40

General description:
The ONE STEP Anti-HIV (1&2) Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) in human whole blood (venous and fingerstick), serum or plasma.

Intended Use:
This test is intended for healthcare professionals and trained healthcare workers to use as an aid in HIV infection diagnosis of adult healthcare patients.

Technical specifications:
Format: Colloidal gold enhanced, rapid immunochromatographic assay.
Specimen types: whole blood (venous and fingerstick), serum or plasma.
Number of Steps: 2 without precision pipetting required.
Sensitivity: 100.0%.
Specificity: 100.0%.
Invalid rate: 0%.
Time to result: 15 minutes.

Manufacturer product reference:
InTec PRODUCTS, INC., ITPW02153‐TC40;

ITPW02153-TC40SA

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

Items supplied with:
40 x Test device pouch containing: 1 test device, 1 desiccant
4 x Sample diluent bottles (2.0ml)
40 x Droppers – Manufacturer Cangzhou Huaao Plastic Products Co., China
40 x Sterile safety lancets - CE Marked, Manufacturer - SteriLance Medical (Suzhou) Inc. China.
40 x Alcohol swabs - CE Marked, Manufacturer - Tianjin Huahong Technology Co. China
1 x IFU"

Items required, but not supplied:
Sterile lancets, alcohol pads, blood sampling tools (sterile gauze pad, venous puncture device, collection tube with EDTA/heparin sodium/sodium citrate for whole blood or plasma, collection tube with no anticoagulant for serum) timer, disposable protective gloves, biohazard waste container

Shelf life:
24 months.

Weight and volume:
Estimated weight: 0.75 kg.
Estimated volume: 2.52 dm3.

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 ONE STEP Anti-HIV (1&2) with accessories for 40 tests.
Secondary packaging: One kit ONE STEP Anti-HIV (1&2) with accessories, 40 tests.

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

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