Monolisa HCV Ag-Ab ULTRA V2 Test,kit/480

General Description:
Monolisa™ HCV Ag-Ab ULTRA V2 is a qualitative enzyme immunoassay that is intended for use as both an aid for diagnosis and as a donor screening test to detect hepatitis C virus capsid and antibodies to hepatitis C virus in human plasma and serum specimens from individual patients and blood donors. The test is intended for use in a laboratory setting by trained laboratory professionals.

Technical specifications:
Technology: Enzyme immunoassay (EIA)
Format: ELISA plate-based assay.
Sample type: Plasma and Serum.
Sample volume: 50µl.
Sensitivity: 100%.
Specificity: 100%.
Time to result: 150 minutes (total incubation time only).

Manufacturer product reference: Bio-Rad, 72562

Kit content:
·1x 5 (R1 Microplates of 8X12 wells).
·1x 1 (R2 Concentrated Washing Solution (20X), vial of 235mL).
·1x 1 (R3 Negative Control, vial (1mL).
·1x 1 (R4 Positive Control, vial (3mL).
·1x 1 (R5a Antigen Positive Control, 1 vial x q.s ad 1ml).
·1x 1 (R5b Antigen Diluent 1 vial x 1mL).
·1x 2 (R6 Conjugate1, vial of 30mL).
·1x 2 (R7 Conjugate 2, vial of 30mL).
·1x 2 (R8 Substrate Buffer, vial of 60mL).
·1x 2 (R9 Chromogen-TMB solution (11X), vial of 5mL).
·1x 3 (R10 Stopping Solution, vial of 28mL).
·1x1 IFU.

Items required Items required, but not supplied:
Consumables:
·Distilled water.
·Sodium hypochlorite (household bleach) and sodium bicarbonate.
·Absorbent paper.
·Adhesive films.
·Disposable gloves.
·Disposable tubes.
Durables:
·Safety glasses.
·Graduated cylinders of 10 ml, 200 ml and 1,000 ml.
Equipment:
·Calibrated automatic or semiautomatic, adjustable or pre-set pipettes or multi pipettes.
·Vortex mixer.
·Automatic, semi-automatic or manual microplate washing system.
·Water-bath, or equivalent microplate incubator, thermostatically set at 37°C ± 1°C
·Container for biohazardous waste.
·Microplate reader equipped with 450, 490 nm and 620-700 nm filters.

Shelf life:
12 months.

Storage and transportation:
Store the kit unopened at 2 to 8°C.
Each item of the kit preserved at 2 to 8°C can be used up to the expiry date mentioned on the package.

Packaging and labeling:
Primary packaging: All contents of Monolisa™ HCV Ag-Ab ULTRA V2 for 480 tests.
Secondary packaging: One kit Monolisa™ HCV Ag-Ab ULTRA V2 Kit/480T.

Weight and volume:
Estimated weight: 1.28 Kg.
Estimated volume: 0.007084 m3.

Useful links:
WHO list of prequalified in vitro diagnostic products: