INSTi HCV - Hepatitis C test

Name: INSTi HCV - Hepatitis C test
Brand: bioLytical Laborities, Inc.
SKU: INSTI HCV
Price: 300.3 CZK
Availability: InStock

CZK 429.00 Save 30%

CZK 300.30

CZK 268.13 excl. VAT

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Delivery 1-2 working days

A quick and easy test for detecting hepatitis C from papillary blood samples for women and men. Very simple to perform, no timers. Results in 15 minutes. For professional use.

Reference

INSTI HCV

In stock

INSTI® HCV Antibody Test – rapid test for the detection of hepatitis C antibodies

Intended use

The INSTI® HCV Antibody Test is a single-use, rapid, flow-through in vitro diagnostic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus (HCV).

The test is intended for use by trained healthcare personnel, is not intended for home self-testing.

A valid test result can be read in as little as approximately 1 minute. A reactive result is preliminary and requires appropriate clinical follow-up and confirmatory testing, such as HCV RNA testing.

About hepatitis C

Hepatitis C virus (HCV) is a blood-borne virus that may cause both acute and chronic liver disease. A newly acquired infection is often asymptomatic, while chronic infection may remain unrecognised for a long period of time.

Antibodies to HCV may indicate a current or past infection. An antibody test alone does not determine whether an infection is currently active; follow-up laboratory tests are used to confirm active infection.

Key benefits

Rapid qualitative result in approximately 1 minute.
Visual result interpretation using blue dots.
Built-in procedural control to verify proper test performance.
Compatible with fingerstick blood, venous whole blood, serum and EDTA plasma.
Complete single-use kit for fingerstick capillary blood collection.

Test principle

The test is a visually read flow-through immunoassay. The test membrane contains a recombinant chimeric HCV antigen and a procedural control spot for verification of the test process.

The assay is designed to detect antibodies to HCV, including IgM and IgG antibodies. A blue control dot confirms test validity and adequate sample addition.

Result interpretation

Non-reactive	Only one blue control dot is visible. HCV antibodies were not detected in the specimen.
Reactive	Two blue dots are visible – a control dot and a test dot. The result is considered preliminary reactive and requires clinical follow-up.
Invalid	The control dot is absent, the membrane has a uniform tint, no dot appears, or only blue specks are visible. Repeat the test with a new specimen and a new kit.

Important: Do not read the result more than 60 minutes after the Clarifying Solution (Solution 3) has been added.

Kit contents

Each single-test pack contains:

1 individually packaged membrane test unit,
1 vial of Sample Diluent – Solution 1,
1 vial of Colour Developer – Solution 2,
1 vial of Clarifying Solution – Solution 3,
1 single-use alcohol swab,
1 single-use sterile lancet,
1 single-use 50 µL pipette,
instructions for use.

Technical parameters

Test type	Qualitative flow-through in vitro immunoassay
Analyte detected	Antibodies to HCV, including IgM and IgG
Specimen type	Fingerstick blood, venous whole blood, serum or EDTA plasma
Time to result	Approximately 1 minute
Diagnostic sensitivity	100% in manufacturer-reported clinical studies
Diagnostic specificity	99.7% in the manufacturer-reported clinical blood-donor study

Storage and warnings

Store the unopened kit in a dry place at +2 to +30 °C.
Use the membrane test unit immediately after opening the foil pouch.
Do not use after the expiry date or if the packaging is damaged.
Do not mix reagents from different lots.
All solutions contain 0.1% sodium azide as a preservative; avoid ingestion and contact with eyes and skin.
For professional in vitro diagnostic use. Follow biosafety precautions and the manufacturer’s instructions when handling specimens.

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