STANDARD Q HIV1/2Ab 3-Linewithacc,kit/25

General Description:
STANDARD Q HIV 1/2 Ab 3 - Line Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies specific to HIV-1 including subtype O and HIV 2 in human serum, plasma or venous and capillary whole blood. The test is for in vitro diagnostic use and intended as an aid to diagnosis of HIV in symptomatic, asymptomatic populations and persons at risk of HIV infection.

Intended Use:
The test is not intended for use on neonates or infants below 2 years. The test is intended to be used by trained healthcare or laboratory professionals or other health care workers who have received appropriate training. This product can be used by trained lay providers operating in point-of-care settings in resource limited countries. The product is not for blood donor screening. The test kit is not automated and does not require any additional instruments. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of HIV infection.

Technical specifications:
Technology: Rapid chromatographic immunoassay.
Format: Test cassette, 25 tests.
Sample type: Serum, plasma or venous and capillary whole blood.
Sample volume: Serum, Plasma 10µl/whole Blood 20 µl.
Sensitivity: Plasma (99.78%) Serum (99.4%), Whole Blood (100%) & Capillary whole Blood (100%).
Specificity: Plasma 100%. Serum (99.92%) & venous whole blood (100%)
Time to result: Minimum of 10 minutes.

Manufacturer product reference:
SD Biosensor, 09HIV30D.

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

Kit content:
25 x Test device pouch containing: 1 test device, 1 desiccant.
1 x Buffer bottle (4.0ml)
25 x Capillary tubes (20ul) - HLB LIFE SCIENCE CO., LTD. Korea
25 x Sterile non-safety lancets - CE Marked, Beijing Ruicheng Medical Supplies Co., Ltd. China
25 x Alcohol swabs - HLB Co., LTD. Healthcare. Korea
1 x IFU

Items required, but not supplied:
General Lab equipment’s:
Anti-coagulant tube containing heparin, EDTA or sodium citrate.
Micropipette and tip
PPE (Personal Protective Equipment).
Biohazard container.

Shelf life:
24 months.

Storage and transportation:
Store the kit unopened at 2 to 40°C, out of direct sunlight.

Packaging and labelling:
Primary packaging: STANDARD Q HIV 1/2 Ab 3-Line Test for 25 tests.
Secondary packaging: One kit STANDARD Q HIV 1/2 Ab 3-Line Kit/25T.

Weight and volume:
Estimated weight: 0.22 Kg.
Estimated volume: 0.002 dm3.

General recommendations:
Carefully read the instruction for using the STANDARD Q HIV 1/2 Ab 3-Line Test.
Check the expiry date at the back of the foil pouch. Use another lot, if expiry date has passed.
Open the foil pouch and check the test device and the colour indicator desiccant pack in foil pouch.

Useful Links.
Public reports of WHO prequalified in vitro diagnostic products.