Hepatitis A IgM Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use.

Hepatitis A IgM Rapid Test

The Hepatitis A IgM Rapid Test (whole blood/serum/plasma) is an in vitro diagnostic test kit for the qualitative, presumptive detection of specific anti-HAV IgM in human blood, serum or plasma. “Hepatitis A” is an acute infectious disease of the liver caused by the “hepatitis A” virus (HAV). About 40% of acute hepatitis cases are caused by HAV. “Hepatitis A” occurs endemically in all parts of the world. There are approximately 1.5 million symptomatic cases per year, and probably tens of millions of infections worldwide. The infection can cause anything from a mild illness lasting a few weeks to severe symptoms lasting for months. Unlike “hepatitis B” and “hepatitis C”, “hepatitis A” infection does not cause chronic liver disease and is rarely fatal, but it can cause debilitating symptoms and fulminant hepatitis (acute liver failure), which in turn carries a high mortality. The “hepatitis A” virus is excreted from the body in the stool, and infection can occur by the oral route. The pathogen can enter the body through contaminated food, unwashed vegetables, fruit, raw or insufficiently heat-treated seafood, or unbottled water. A single infected person in our immediate surroundings is enough for the disease to develop, if they pass on the virus in some way, even by touching with their hands. This product can be ordered for professional use.

Hepatitis A IgM Rapid Test Specification

Product name: HAV IgM Rapid Test
Sample: whole blood/serum/plasma
Packaging: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
Expiry date:30/11/2027

Contents of the Hepatitis A IgM Rapid Test Kit

• 1 test cassette
• 1 disposable pipette
• 1 HAV buffer solution
• 1 finger lancet
• 1 alcohol swab
• 1 instructions for use in Hungarian

How to use the finger lancet

1. Remove the yellow single-use finger lancet from the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be ejected automatically.
3. After use, discard the lancet in the waste bin.

The visual aid is intended exclusively for healthcare professionals. 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. Remove the test from the sealed pouch and place it on a clean, level surface. Label the test with the patient or control identification. For best results, the assay should be performed within one hour after opening the pouch.

2.A For serum/plasma samples:

Using the supplied disposable pipette, draw up the sample to the fill line and dispense 1 drop of serum/plasma (approx. 5 uL) into the sample well (S), then add 3 drops of buffer solution.

2.B For whole blood samples:

Using the supplied disposable pipette, draw up the sample to 0.5–1 cm above the fill line, dispense 2 drops of blood (approx. 10 μl) into the sample well (S) of the test device, then add 3 drops of buffer solution.

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

3. During the process, the color migrates across the membrane.

4. The result must be read after 15 minutes. After 20 minutes the result is invalid.

Interpretation of results

Positive

Two distinct red lines appear. One line appears in the control region (C) and the other in the test region (T). A line of a color between pink and red in the test region (T), however faint, indicates a positive result.

Negative

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

Invalid

Only one red line appears in the test region (T) and no red line appears in the control region (C). / No red line appears at all. The most likely causes are insufficient sample volume or incorrect use of the device.

Performance of the Hepatitis A IgM Rapid Test

• Relative sensitivity: 99.5% (97.5%-99.9%)
• Relative specificity: 99.3% (95.9%-99.9%)
• Overall agreement: 99.4% (98.0%-99.8%)

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

ATTENTION!
Pursuant to Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons this 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 under 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 fulfilling the legal obligations relating to the Buyer's procurement procedure, as this falls within the Buyer's competence; its liability is limited exclusively to information on intended use and to the goods delivered.