Hepatitis C Rapid Test Kit (40 tests/box)

• The price includes 5% VAT.

• This product can be ordered for professional use only.

Hepatitis C Rapid Test

The Hepatitis C rapid test is an easy-to-use, painless and fast solution for detecting the virus. It gives a reliable result from a blood sample within a few minutes, allowing early detection and the start of appropriate treatment. It is ideal for people who have been exposed to risk factors, for example through tattooing, body piercing, blood transfusion or intravenous drug use.

The hepatitis C virus (HCV) is an infection affecting the liver that can cause acute and chronic disease. The virus is spread primarily through blood, for example through the use of non-sterile medical equipment, blood transfusion or intravenous drug use. It is estimated that more than 70 million people worldwide live with chronic hepatitis C infection, which can lead to serious complications such as liver cirrhosis or liver cancer. Early detection is essential, as modern antiviral treatments offer a 95% cure rate. The infection is often asymptomatic, so regular screening is particularly important for at-risk groups.

The HCV rapid test is a fast and reliable method for the qualitative detection of antibodies to the hepatitis C virus in human whole blood, serum or plasma. The test is intended for professional in vitro diagnostic use only. It is an ideal choice for healthcare professionals for the rapid detection of HCV antibodies.

Hepatitis C Rapid Test Specification

Product name: HCV rapid test cassette
Sample: whole blood/serum/plasma
Packaging: 40 pcs/box
Format: Cassette test
Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Telephone: +86-571-56267891; info@alltests.com.cn
EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; info@medneteurope.com
Expiry date:31.07.2028.

Contents of the Hepatitis C Rapid Test Kit

• 40 test cassettes
• 40 disposable pipettes
• 2 buffer solution bottles
• 1 instructions for use in Hungarian

How to use the finger lancet

1. Take the yellow single-use finger lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be released automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended for healthcare professionals only. The product is not intended for self-testing.

Test procedure

Read the Instructions for Use carefully before performing the test! Collect the sample as described in the instructions for use.

Before use, allow the devices, reagents, samples and/or controls to reach room temperature (15°C–30°C).

After sample collection:

1. Before opening, allow the pouch to come to room temperature. Remove the test cassette from the sealed pouch and use it as soon as possible. The best results are obtained if the assay is performed within one hour. For best results, the assay must be performed within one hour of opening!

2.A For serum/plasma samples:

Hold the pipette vertically and dispense 1 drop of serum or plasma (approx. 25 μL) into the sample well (S) of the test, then add 2 drops of buffer solution (approx. 80 μL) and start the timer!

2.B For venipuncture whole blood samples:

Hold the dropper vertically and dispense 2 drops of whole blood (approx. 50 μL) into the sample well (S), then add 2 drops of buffer (approx. 80 μL) and start the timer!

2.C For fingerstick whole blood samples:

Fill the capillary tube and dispense approx. 2 drops (50 μL) of fingerstick whole blood sample into the sample well (S) of the test cassette, then add 2 drops of buffer (approx. 80 μL). Start the timer.

Note: Avoid trapping air bubbles in the sample well (S), and do not apply any solution to the result area!

3. Wait for the coloured line(s) to appear!

4. The result must be read after 10 minutes. After 20 minutes the result is invalid.

Note: Do not use the buffer solution 6 months after opening!

Interpretation of results

Positive

Two distinct coloured lines appear. One line appears in the control region (C) and the other in the test region (T). A positive result indicates the detection of HCV antibodies in the sample in the test region.

NOTE: The intensity of the colour in the test line region (T) varies depending on the concentration of HCV antibodies in the sample. Therefore, any shade of colour in the test region should be considered positive.

Negative

One coloured line appears in the control region (C). No line appears in the test region (T).

Invalid

No visible line appears in the control region (C). Insufficient sample volume, incorrect procedural technique or expired tests are the most likely reasons for an invalid result. Please review the procedure again, then repeat the test with a new test! If the problem persists, contact your local distributor!

Performance of the Hepatitis C Rapid Test

The HCV rapid test (whole blood/serum/plasma) was compared with a CE-marked EIA or CMIA test. The results show that the HCV rapid test cassette (whole blood/serum/plasma) has a relative sensitivity of 100% and a relative specificity of 100%.

The diagnostic products specified in Section 3 (5) of EüM Decree 2/2008 (I. 8.) on products that may be sold in pharmacies and must be kept in stock, namely in vitro diagnostic products (rapid tests) for the diagnosis of HIV and hepatitis B, C and D, may be kept only in hospital pharmacies for inpatient hospital use. The test may be purchased only by healthcare institutions, physicians or licensed organisations engaged in AIDS screening!

The test may be used only by competent professional staff and healthcare professionals! Carbon Web Kft. accepts no liability for its use for self-testing purposes.

ATTENTION!
Pursuant to Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right set out in Section 20 (the consumer's right of withdrawal) e) in respect of a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for the fulfilment of legal obligations relating to the Buyer's procurement procedure, as this falls within the Buyer's remit; its liability is limited solely to information on the intended use and to the goods delivered.