TrinScreen HIV, kit/100

General Description:
TrinScreen HIV test is single use, rapid immunoassay for the qualitative detection of antibodies to human immunodeficiency virus type 1 and 2 in serum, plasma, and whole blood (venipuncture and fingerstick). 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.

Intend Use:
The test is not intended for use on neonates or infants below two years. The TrinScreen HIV test is intended to be performed by a healthcare professional at the point-of-care (POC) as an aid in the diagnosis of HIV infection.

Technical specifications:
Technology: Rapid immunoassay based on the immunochromatographic sandwich principle.
Format: Test cassette.
Sample type: Serum, plasma, or whole blood.
Number of steps: 2 steps in total No step with precision pipetting (1 drop of specimen is added using the pipette supplied with the kit)
Sensitivity: 100%.
Specificity: 100%.
Time to result: Minimum of 10 minutes. (No later than 12 minutes incubation time.)

Manufacturer product reference:
Trinity Biotech, 5551100.

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

Kit content:
·100 x Test device pouch containing: 1 test device, 1 desiccant.
·4 x Wash Solution bottles (2.0ml)
·100 x Disposable pipettes - CE Marked, Zhejiang Sorfa Life Science Research Co. China
·100 x Sterile non-safety lancets - CE Marked, Medtrue Enterprise Co., Ltd. China
·100 x Alcohol swabs - CE Marked, Medtrue Enterprise Co., Ltd. China
·1 x IFU.

Items required, but not supplied:
Timer or stopwatch. • Suitable pen to use for labelling samples and tests. • Biohazard disposal waste container. Disposable gloves and/or protective clothing.

Shelf life:
24 months.

Storage and transportation:
Store the kit unopened at 2 to 30°C.

Packaging and labeling:
Primary packaging: All contnets of TrinScreen HIV Kit/ Test for 100 tests.
Secondary packaging: One kit TrinScreen HIV Kit/100 tests.

Weight and volume:
Estimated weight: 1.1 Kg.
Estimated volume: 0.006 m3.

General recommendations:
1.Read the Instructions for Use completely before using the product. The instructions must be followed carefully as not doing so may result in inaccurate results.
2.TrinScreen HIV test is for diagnostic use only and is not to be used for screening donors of blood, plasma, cells or tissues.
3.Perform test at room temperature.

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).