Panbio HIV Verific w acce Kit/20 Test

General Description:
“The Panbio HIV Verification Test is a manual in vitro diagnostic rapid test (immunochromatographic test based on sandwich principle) for the qualitative detection of antibodies to HIV-1 and HIV-2 in human serum, plasma, venous and capillary whole blood. A reactive result should be confirmed by supplemental testing according to a validated HIV testing algorithm. The test is for professional use only.

Intended Use:
For near-patient testing as an aid in the diagnosis of HIV infection. The product may be used in any laboratory and nonlaboratory environment that meets the requirements specified in the Instructions for Use. This test is not intended to be used as an HIV screening test for blood donation and not suitable for testing infants younger than 18 months.

Technical specifications:
Technology: Lateral flow immunochromatographic assay
Sample type: serum, plasma, venous and capillary whole blood.
Number of steps: 2 steps in total No step with precision pipetting.
Sample volume: 1 drop (approximately 25 µL) of serum, plasma venous or capillary whole blood. Sensitivity: 100%.
Specificity: 99.7%.
Time to result: Between 15-20 mins.

Manufacturer product reference: Abbott Diagnostics Medical Co
., Ltd, Germany 29011-AW20.

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

Items supplied with:
·20 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Buffer bottle (3.0ml).
·20 x Specimen droppers (Serum/Plasma/Venipuncture Whole Blood) – manufacturer - Jiangsu Kehua Medical Instrument, China,
·20 x Sterile safety lancets - manufacturer - Ningbo Medisun Medicals Co., Ltd. China - CE Marked,
·20 x Alcohol swabs - manufacturer - Changzhou Maokang Medical Products Co., Ltd. China - CE Marked.
·20 x Fingerstick blood droppers. Manufacturer - Jiangsu Kehua Medical Instrument, China,
·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 and biohazard waste containers for sharps and non-sharps.
·Pen/Marker, disposable gloves and/or protective clothing.

Shelf life:
24 months.

Weight and volume:
Estimated weight: 5.3kg.
Estimated volume: 78.23 dm3.

Storage and transportation condition:
2 to 30°C.

Packaging and labeling:
Primary packaging: All contents of Panbio HIV Verification Test-1/2 for 20 tests.
Secondary packaging: One kit Panbio HIV Verification Test 20 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).