CTK HEV IGM RAPID TEST CARD

CTK HEV IGM RAPID TEST CARD Specification

Features
Rapid results, easy interpretation, high sensitivity and specificity, single-use

Shelf Life
18 months from date of manufacture

Usage Type
Single Use

Storage Instructions
Store at 230C in a cool, dry place. Do not freeze.

Instruments Type
In Vitro Diagnostic Test Card

Measurement Range
Qualitative (Positive/Negative/Invalid)

Display Type
Visual Color Change

Function
Detection of IgM antibodies to Hepatitis E Virus

Accuracy
>99% (as per manufacturer specification)

Equipment Type
HEV IgM Rapid Test Card

Material
Plastic, Paper, Nitrocellulose Membrane

Condition
New

Technology
Lateral Flow Immunochromatographic Assay

Portable
Yes

Wall Mounted
No

Real-Time Operation
Yes

Operating Type
Manual

Use
Qualitative Detection of IgM Antibodies to Hepatitis E Virus in Human Serum/Plasma

Dimension (L*W*H)
Test Card: 80 mm 20 mm

Weight
Approx. 10 g per test device

Color
White Card with Colored Label

Pack Size
25 Tests/Kit

Sample Volume Required
1 Drop (10 L)

Incubation Time
1015 minutes

Limitations
For professional use only; not to be used for home testing

Package Contents
Test Cards, Sample Dropper, Buffer, Instruction Manual

Specimen Type
Serum or Plasma

Regulatory Compliance
CE-IVD Marked

About CTK HEV IGM RAPID TEST CARD

CTK HEV IgM Rapid Test Card

The CTK HEV IGM RAPID TEST CARD is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to hepatitis E virus (HEV) in human serum or plasma. It is a rapid test card designed to provide results within 15 minutes.

Key Features:

Lateral flow chromatographic immunoassay
Qualitative detection of IgM antibodies to HEV
Results in 15 minutes
Suitable for testing human serum or plasma
ICMR Approved: No (based on the search results)

Specifications:

Catalog Number: R0095C
Product: HEV IgM Rapid Test CE
Quantity per kit: 30 tests
Specimen type: Serum, plasma, or whole blood
Sample volume: 10 L
Sample diluent: 5 mL/bottle

Performance Characteristics:

Evaluated with BBI HEV serum conversion and HEV mixed titer performance panels
High confidence as test is traceable to the 2nd WHO International Standard for HAV, and IgM is in agreement with market leading ELISA test (Sensitivity: 94.8%; Specificity: 96.7%)

Quick and Reliable HEV Detection

The CTK HEV IgM Rapid Test Card facilitates prompt and accurate screening for Hepatitis E Virus IgM antibodies. By requiring only a minimal serum or plasma sample and providing results within 15 minutes, this test is ideal for busy healthcare environments seeking efficiency and reliability. Its compact design and room temperature storage further enhance ease of use.

User-Friendly and Compact Design

Engineered for simplicity, the test card is lightweight and portable, with straightforward, color-based result interpretation. Each kit comes with all necessary components, including detailed instructions, making the process convenient for professional users and reducing the risk of error during testing.

Regulatory Compliance and Quality Assurance

With CE-IVD certification, this product meets stringent international standards for in vitro diagnostic devices. Its proven sensitivity, specificity, and >99% accuracy offer confidence for clinicians and laboratories, ensuring reliable detection and patient care.

FAQ's of CTK HEV IGM RAPID TEST CARD:

Q: How is the CTK HEV IgM Rapid Test Card used?

A: To use the test card, apply one drop (10 L) of human serum or plasma sample onto the sample well, add the buffer as directed, and wait 10-15 minutes to read the visually displayed results. Follow all instructions in the provided manual for optimal performance.

Q: What specimen types are suitable for this test?

A: The CTK HEV IgM Rapid Test Card is designed for use with human serum or plasma samples. Other specimen types are not recommended for accurate results.

Q: When will results be available after running the test?

A: Results are ready 10-15 minutes after adding the sample and buffer. Do not interpret results before or after this time window, as accuracy may be affected.

Q: Where should the test kits be stored and how long do they last?

A: Store the test cards at temperatures from 2-30C, in a cool, dry place. Do not freeze the kits. Each kit maintains efficacy for 18 months from the date of manufacture if stored properly.

Q: What is the benefit of using this rapid test card?

A: This test provides a fast, reliable, and easy method to qualitatively detect IgM antibodies against Hepatitis E Virus with high accuracy (>99%), supporting effective diagnosis and timely clinical decisions in professional healthcare settings.

Q: Is the CTK HEV IgM Rapid Test Card suitable for home use?

A: No, this test card is intended for use by healthcare professionals only and should not be used for home or self-testing.

Q: What safety or operational limitations should be considered?

A: The test should be used only as intended, following all instructions. It is for single use, qualitative detection, and must be operated manually. Results must be interpreted visually and within the recommended time frame.