Inno-lia HCV Score Confirmatory,kit/20

General Description:
INNO-LIA HCV Score, is a line immuno assay (version 3.0) Qualitative confirmation of a positive result of a Hepatitis C antibodies test

Technical specifications:
Technology: line immuno assay
Format: Strips, 20 tests
Sample type: Serum, plasma
Sample volume: 10-20µl
Sensitivity: 100%
Specificity: 93.7%
Time to result: Depend on protocol (4 hrs, 5 hrs or 18 hrs)

Manufacturer product reference: Fujirebio, 80538.

Kit content:
1.Strips, 20
2.Sample diluent, 1 bottle (30ml)
3.Conjugate, 1 bottle (45ml)
4.Negative control, 1 bottle (0.12ml)
5.Positive control, 1 bottle (0.12ml)
6.BCIP/NBT Substrate, 1 bottle (45ml)
7.Stop solution, 1 bottle (45ml)
8.Wash solution, 1 bottle (45ml)
9.Incubation tray, 2 units with 11 troughs each
10.Adhesive sealers, 5
11.Data reporting sheet, 1
12.Reading card, 1
13.Instructions for use

Items required, but not supplied:
1.Distilled or deionised water, precision pipettes (with disposable tip for 10μL, 20-200μL, and 200-1000μL), orbital shaker or rocker (for incubation).
2.Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), vacuum tube needle, needle holder and centrifuge.
3.Disposable gloves, anti-septic swabs, absorbent paper, protective glasses, timer, container for biohazard disposables and disinfectant (for equipment and surfaces).

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

Storage and transportation:
Between 2-8°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: 20 test strips of INNO-LIA HCV Score, accessories and instructions for use, must be contained in one kit.

Weight and volume:
Estimated weight: 0.502Kg
Estimated volume: 2.61dm³

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.
4. Note that serum or plasma samples require supporting equipment and supplies, therefore a laboratory environment is recommended with adequately trained staff.