FirstResponseHIV1+2/SyphComboCard,kit/50

General description:
First Response HIV 1+2 / Syphilis Combo Card Test is a rapid immunochromatographic assay, for the qualitative of antibodies (IgG & IgM) specific to HIV (type 1 & 2) and Treponema pallidum in human serum, plasma or whole blood. It is intended for use by healthcare professionals and trained user. Reactive specimens should be confirmed further with ELISA, Western Blot or TPHA.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 50 tests
Sample type: Whole blood, serum, plasma
Sample volume: 20μl
Sensitivity: 100.00% (HIV 1/2), 99.00% (Syphilis)
Specificity: 99.50% (HIV 1/2), 100.00% (Syphilis)
Invalid rate: 0%
Time to result: Interpret the test result at 15 minutes. Do not read test result after 25 minutes.

Manufacturer product reference: Premier Medical Corporation Private Limited, I20FRC50

Items supplied with:
1.Test device pouch containing 1 test device & 1 desiccant, 50
2.Assay buffer bottle (2.5ml), 2
3.Specimen transfer device, 50
4.Sterile lancet, 50
5.Alcohol swab, 50
6.Instructions for use, 1

Items required, but not supplied:
Disposable protective gloves, marker pen, timer, extra lancets and alcohol swabs if needed, biohazard waste container and sharp disposable box, sterile gauze pads, venipuncture blood collection kit (if whole blood is collected by venipuncture)

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

Weight and volume:
Estimated weight: 0.410 kg
Estimated volume: 0.0018 m3

Storage and transportation condition:
Between 4 - 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of First Response HIV1+2/Syphilis Combo Card for 50 tests
Secondary packaging: One kit First Response HIV1+2/Syphilis Combo Card, 50 tests

General recommendations:
1.Only initiate testing when all components of kit reach the temperature of the environment in which the test will be performed.
2.Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
3.Do not substitute reagents from other kits/batches.