m-PIMA HIV-1/2 Detect Cartridge, kit/50

General description:
m-PIMA HIV-1/2 Detect is a qualitative nucleic acid amplification test for the detection of human immunodeficiency virus (HIV) type 1 groups M/N and O, and type 2 RNA in human whole blood and plasma specimens. It can be used as an aid in the diagnosis of HIV infection in pediatric and adult individuals, or as an additional test when specimens have already been tested using alternative methods.

Technical specifications:
·The test can be used in the laboratory as well as non-laboratory environments by trained health care or laboratory professionals or other health care workers receiving appropriate training.
·In order to perform an m-PIMA HIV-1/2 Detect test, the m-PIMA Analyser is required.
·Single-use cartridge that is capped and sealed after sample collection to contain infectious materials and eliminate the possibility of accidental reuse or cross-contamination with other samples.
·Validated specimen types: Venous (EDTA) and capillary whole blood; EDTA plasma
·Sample volume: 25μl
·Time to result: 56 minutes (3-4 min hands-on time, 52 min on the instrument)
·Performance characteristics: Sensitivity (Infants -99.3%, Adults-94%), Specificity (Infants-100%, Adults-100%).

Manufacture product reference: 27011R050 (Abbott Rapid Diagnostics Jena GmbH)

Items supplied with:
·50 x Individually pouched test cartridges
·1 x Guide

Items supplied with:
·50 x Individually pouched test cartridges
·1 x Guide

Items required, but not supplied:
·m-PIMA Analyzer (product code 27030R001) with installed software, and accessories.
·Finger Stick Sample Collection Kit-100 (product code 260400199), Neonatal Sample Collection Kit-100 (product code 270400200), Plastic Capillaries plain (product code 270400005), Plastic Capillaries EDTA-K2 (product code 270400006)

Shelf life:
13 months from the date of manufacturing.

Storage and transportation instructions:
Store cartridges at 4 - 30 °C. Once removed from their protective pouch, cartridges are stable for up to 10 minutes at 40 °C and 90% relative humidity. DO NOT freeze the test cartridges.

Weight and Volume:
Estimated weight: 1.8 kg
Estimated volume: 12.7 dm3

Packaging and Labeling:
Primary packaging: All contents of m-PIMA HIV-1/2 Detect Cartridge, kit for 50 tests
Secondary packaging: One kit m-PIMA HIV-1/2 Detect Cartridge, 50 tests