MERISCREEN HIV 1-2 WB, kit/50Tests

General Description:
MERISCREEN HIV 1-2 WB Test is a single use, qualitative, screening, in-vitro diagnostic immunochromatography assay and used for detection of antibodies (IgG, IgA and IgM) specific to HIV-1 and HIV-2 in human fingerstick whole blood, venous whole blood, serum or plasma specimens
.

Intended Use:
The test is intended for trained users (either in laboratory or in point-of-care setting) to aid in the diagnosis of infection with HIV-1 and HIV-2 and for the diagnosis of HIV infection in symptomatic, asymptomatic and persons at risk of HIV infections. It is not intended for testing children below 2 years. The assay is manual and does not require additional instrument
.

Technical specifications:
Type: Rapid immunochromatographic test kit.
Format: Lateral flow cassette, 100 tests.
Sample type: Serum, Plasma, Whole blood (Fingerstick & Venous).
Sample volume: 10 µl Serum/ Plasma or 20 µl Whole Blood.
Specimen transfer device: Capillary Tube.
Number of Steps: 3 steps for whole blood 2 steps for serum/plasma.
Buffer Volume: 3 drops.
Read time: 20 minutes.
Sensitivity: 100%.
Specificity: 100%.

Manufacturer product reference:
Meril Diagnostics Pvt. Ltd., India, HVWRPD-06.

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

Kit content:
·50 x Test device pouch containing: 1 test device, 1 desiccant.
·3 x Assay buffer bottles (3.0ml)
·50 x Specimen transfer device - Jiangsu Kehua Medical Instrument, China ,
·50 x Sterile non-safety lancets - CE Marked, Medtrue Enterprise Co., Ltd. China
·50 x Alcohol swabs - Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. India
·1 x IFU.

Items required, but not supplied:
·Timer, plaster, and Pen.
·New pair of disposable gloves.
·Sterile gauze (for fingerstick whole blood specimens).
·Centrifuge (for serum/plasma specimens only).
·Biohazard Sharp Box.
·Non-sharp disposal container.
·Venous blood collection materials and precision pipette plus tips).

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

Storage and transportation:
Between 2 - 30°C.

Packaging and labeling:
Primary packaging: All contents of MERISCREEN HIV 1-2 WB HIV 1/2, for 50 tests.
Secondary packaging: One kit MERISCREEN HIV 1-2 WB HIV 1/2, 50 tests.

Weight and volume:
Estimated weight: 0.47 kg.
Estimated volume: 0.002275m3

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).