JMITRA HEPACARD HBSAG RAPID TEST CARD

JMITRA HEPACARD HBSAG RAPID TEST CARD Specification

Instruments Type
In Vitro Diagnostic Device

Features
Rapid result, easy to use, one-step operation, clear result interpretation, room temperature storage

Function
Qualitative identification of HBsAg

Display Type
Visual Line Indication (analog)

Shelf Life
24 months from manufacturing date

Measurement Range
QualitativeDetects presence or absence of HBsAg

Usage Type
Single Use

Accuracy
>99% (as per manufacturer)

Storage Instructions
Store at 230C in a dry place, away from direct sunlight

Equipment Type
Diagnostic Rapid Test Card

Material
High-quality plastic and membrane strips

Condition
New

Technology
Lateral Flow Immunoassay

Portable
Yes

Wall Mounted
No

Real-Time Operation
Yes

Operating Type
Manual

Use
Detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma

Dimension (L*W*H)
Standard test card size (approx. 80mm x 25mm x 4mm)

Weight
Approx. 5 grams per test card

Color
White card with marked result window

Biological Risk
Single use only, dispose as biomedical waste

Specimen Type
Human serum or plasma

Intended Users
Clinical laboratories, hospitals, diagnostic centers

Result Time
20 minutes

Manufactured By
J. Mitra & Co. Pvt. Ltd.

Package Contents
25 individually pouched test cards, 1 instruction leaflet, disposable droppers

Specificity
High

Sensitivity
High (typically 99%)

Lot Number & Expiry
Printed on packaging

About JMITRA HEPACARD HBSAG RAPID TEST CARD

Hepacard is visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human serum or plasma.The assay is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus(HBV).

Salient Features

Detects all the 11 subtype of HBsAg.
Antigen Sensitivity- 0.5 ng/ml.
No sample preparation required.
See through Device for easy result interpretation.
Shelf life-30 months at 2-30C.
WHO Evaluated with 100% Sensitivity.

Principle

HEPACARD is a one-step immunoassay based on the antigen capture, or "sandwich principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the signal reagent. If the sample contains HBsAg, the collodial gold-antibody conjugate binds to the antigen, forming an antigen-antibody-collodial gold complex. The complex then migrates through the nitrocellulose strip by capillary action. When the complex meets the line of immobilized antibody(Test line) "T, the complex is trapped forming an antibody-antigen-antibody colldial gold complex.

Rapid and Reliable HBsAg Screening

The HEPACARD HBSAG RAPID TEST CARD delivers reliable results within 20 minutes, ensuring timely diagnosis and streamlining clinical workflow. This lateral flow immunoassay leverages high-quality plastic and membrane strips to offer consistent accuracy over a 24-month shelf life. Designed for ease of use, the visual analog display enables prompt result interpretation in a single operational step.

Simple, Safe, and User-Friendly

Intended for clinical professionals, this test card requires only human serum or plasma, with no complex equipment needed. Its clear instructions, single-use packaging, and manual operation minimize handling risks and maintain biosafety. The compact, lightweight design further enhances portability and convenient storage, making it ideal for varied medical settings.

FAQ's of JMITRA HEPACARD HBSAG RAPID TEST CARD:

Q: How do I use the JMITRA HEPACARD HBSAG RAPID TEST CARD?

A: To use the test card, add the required amount of human serum or plasma sample to the indicated area using the disposable dropper. Wait 20 minutes for the results to display in the marked result window. Detailed instructions are provided in the included leaflet.

Q: What specimen types are compatible with this rapid test?

A: This test card is validated for use with human serum or plasma collected in clinical settings. Other specimen types are not recommended.

Q: Where should I store the test cards for optimal performance?

A: Store the test cards at 2-30C in a dry place, away from direct sunlight and moisture. Keeping them within the temperature range outlined on the packaging maintains their accuracy and efficacy.

Q: What are the key benefits of using this rapid test for HBsAg detection?

A: The test offers over 99% accuracy, provides rapid results within 20 minutes, and is easy to operate without specialized equipment. Its portability and room temperature storage make it highly practical for diverse healthcare environments.

Q: When is it appropriate to use this diagnostic test?

A: Use this test card for routine HBsAg screening, pre-transfusion safety checks, or hepatitis B diagnostics in clinical laboratories, hospitals, or diagnostic centers as part of standard clinical protocols.

Q: How do I dispose of the test card after use?

A: After single use, dispose of the test card and any associated materials as biomedical waste, following your facility's guidelines for the disposal of diagnostic medical devices.

Q: What does a positive or negative result indicate on this test?

A: A positive result indicates the presence of Hepatitis B Surface Antigen in the tested serum or plasma, suggesting active hepatitis B infection. A negative result means HBsAg was not detected, but further testing may be necessary if infection is still suspected clinically.