ABON HIV 1/2/O Tri-Line HIVRDT,kit/40

General description:
ABON HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device is an in vitro diagnostic rapid immunochromatographic assay for the qualitative detection of antibodies to HIV-1, including subtype O, and HIV-2 in venous and capillary whole blood, serum, and plasma specimens. Used as an aid in the diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. This product has not been evaluated on paediatric and neonatal specimens.

Technical specifications:
Sample type: Whole blood/Serum and Plasma
Sample volume: 25µl (serum/plasma); 50µl (whole blood)
Sensitivity: 100%
Specificity: 99.7%
Time to result: 10-20 mins

Manufacturer product reference:
ABON Biopharm Hangzhou Co., Ltd., China. IHI-T402WG

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
·40 x Specimen dropper for Fingerstick Whole Blood (Manufacturer: Jiangsu Kehua Medical Instrument, China)
·40 x Specimen dropper for Serum/Plasma/Venipuncture Whole Blood
·40 x Sterile safety lancets (Manufacturer: Tianjin Huahong Technology Co., Ltd. China - CE Marked)
·40 x Alcohol swabs (Manufacturer: Changzhou Maokang Medical Products Co., Ltd. China - CE Marked)
·2 x Buffer bottles (3.0ml)
·1 x IFU

Items required, but not supplied:
Specimen collection equipment and containers, cotton wool or gauze pad (for fingerstick whole blood only), centrifuge, timer, biohazard waste containers for sharps and non sharps

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

Weight and volume:
Estimated weight: 0.699kg
Estimated volume: 3.24dm3

Storage and transportation condition:
The test kit should be stored at 2 - 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of ABON HIV 1/2/O Tri-Line with accessories for 40 tests
Secondary packaging: One kit ABON HIV 1/2/O Tri-Line, 40 tests

General recommendations:
Public reports of WHO prequalified in vitro diagnostic products:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).