VISITECT CD4 Advanced Disease, kit/25T

General description:
The VISITECT CD4 Advanced Disease Rapid Test is an immunochromatographic assay that estimates full length CD4 protein associated with CD4+ T cells in human whole blood and is directly correlated with CD4+ T cell levels.

Intended Use:
The VISITECT CD4 Advanced Disease Rapid Test is for use as an aid in the management of patients with advanced HIV disease (patients with CD4 count below 200 cells/μL). This visually read test is designed to be used at the point-of-care and therefore has utility in decentralized diagnostic settings. The test is for professional use only, not intended for individual les than 5 years of age, determination of HIV status and self-testing.

Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Format: Cassette, 25 tests.
Sample type: Human whole blood (capillary or EDTA venous)
Specimen volume: 30 µL of venous or capillary whole blood.
Sensitivity: Venous whole blood (96%) /Capillary whole blood (95%).
Specificity: Venous whole blood (96%)/capillary whole blood 97%.
Reading time: 40 Minutes.

Manufacturer product reference: AccuBio Ltd., UK. AB376

QMS/Regulatory information:
·CE Marked
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·25 x Test device pouch containing: 1 test device, 1 desiccant
·1 x Buffer bottle (7.0ml)
·25 x Sampling devices (Manufacturer: Drummond Scientific LLC. USA)
·25 x Sterile safety lancets (Manufacturer: SteriLance Medical (Suzhou) Inc. China – CE Marked)
·25 x Alcohol swabs (Manufacturer: Vitrex Medical A/S, Denmark)
·1 x Job aid for capillary whole blood specimens
·1 x Job aid for venous whole blood specimens
·1 x IFU

Items required, but not supplied:
New pair of disposable gloves, timer, pen, and Sharps/biohazard bin.
Dry gauze or tissue, precision pipette capable of delivering 30μL plus disposable tips (venous blood only), EDTA blood collection tube (venous blood only) and Plaster.

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

Weight & volume:
Estimated weight: 0.42kg
Estimated volume: 0.0021m3

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

Packaging & labelling:
Primary packaging: All contents of VISITECT CD4 Advanced Disease, kit of 25 tests.
Secondary packaging: One kit VISITECT CD4 Advanced Disease, kit/25 tests.

General recommendations:
PQD x_0384-077-00_VISTECT-CD4_AdvancedDisease_v5.0.pdf (who.int)
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).