One Step HIV1/2, 18Gsafetylancet,kit/25T

General description:
Wondfo One Step HIV 1/2 Whole Blood/Serum/Plasma Test is a manual qualitative in vitro diagnostic for the detection of HIV 1/2 antibodies in human venous whole blood, capillary whole blood, serum and plasma specimens.

Intended Use:
The test is intended for professional use in either laboratory or point of care settings. It is intended for aiding the diagnosis of HIV infection in symptomatic, symptomatic populations and persons at risk of HIV infection. It is not intended for testing children below 2 years and it is not intended for blood donor screening.

Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Test format: Cassette.
Specimen type: Fingertip whole blood, venous whole blood, Serum and plasma.
Clinical sensitivity: 100.0%
Clinical specificity: 100%
Time to result: 15 minutes. Do not wait more than 30 minutes.

Manufacturer product reference:
Guangzhou Wondfo Biotech Co., Ltd, W006-P0046

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

Items supplied with:
25 x Test device pouch containing: 1 test device, 1 dropper and 1 desiccant
1 x Buffer bottle (5.0ml)
25 x 18G safety lancets - CE Marked, Ningbo Medisun Medicals Co., Ltd. China
25 x Alcohol swabs - CE Marked, Beijing Ruicheng Medical Supplies Co., Ltd. China
1 x IFU

Items required, but not supplied:
Specimen collection containers, centrifuge (for serum/plasma specimen only), capillary tube (for fingerstick whole blood only), timer, protective gloves, specimen, and test waste container

Shelf life:
24 months.

Weight and volume:
Estimated weight: 0.294 Kg.
Estimated volume: 0.002 m³.

Storage and transportation condition:
The test kit and sample diluent should be stored at 2 to 30°C. Protect against humidity and direct sunlight. Do not freeze.

Packaging and labelling:
Primary packaging: All contents of One Step HIV1/2 Whole Blood/Serum/Plasma Test with 21G safety lancet for 25 tests.
Secondary packaging: One kit One Step HIV1/2 Whole Blood/Serum/Plasma Test with 21G safety lancet, 25 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.
Do not use the kit if pouch is punctured or not well sealed.
Do not mix buffer/test devices from different kit lots.
Apply standard biosafety precautions when handling and disposing of potentially infectious material.

Useful links:
Public reports of WHO prequalified in vitro diagnostic products.