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TB Rapid Test Kit Cassette

TB Rapid Test Kit Cassette
TB Rapid Test Kit Cassette
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Product Code : 09
Product Description

We are counted among some of the most trusted name engaged in offering of a huge gamut of Lab Reagent Tuberculosis TB Rapid Test Kits Cassette. This rapid test kits cassette is extensively used for detecting tuberculosis in patients. Rapid test kits cassette is designed under the firm direction of the adroit experts utilizing quality approved medical grade materials, sourced from the trusted experts. Also, the offered Lab Reagent Tuberculosis TB Rapid Test Kits Cassette can be availed from us at industry leading rates from us.

This rapid Gold Immunoassay Kit for the Antibody IgG to Tuberculosis (TB) is an in-vitro immunoassay for the qualitative detection of Anti-TB antibody IgG in the human serum or plasma in just one step. It is for the diagnosis of early infection and epidemic survey.

PRINCIPLE

The purified specific recombinant TB antigen is immobilized on the nitrocellulose membrane at the test line region and another specific TB-Ag conjugate to the colloidal-gold is coupled on the label pad. To perform the test, a sample must be added to the sample well of the test card. The sample then flows through the label pad. If it contains Antibody IgG to Tuberculosis, the antibody will bind to the antigen coated on the colloidal-gold particles to form antibody-antigen-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region and reacts with the specific recombinant TB antigen to produce a pink line on the membrane. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the device is functioning properly. If Antibody IgG to Tuberculosis (TB) is not present or lower than the detection level of the test, only the control line will be visible. If the control line is not developed, the test is invalid. The pink color intensity will reflect the antibody intensity in the sample; this test is fast and easy to operate.

MATERIALS PROVIDED

  • Antibody IgG to Tuberculosis test card or strip

  • Each cassette or strip contains a test strip with TB antigen on the test region of the membrane and colored Tuberculosis antigen-gold-conjugate pad.

SAMPLE SELECTION AND PRESERVATION

Blood serum samples are routinely prepared form vein the blood plasma samples are routinely prepared with an anticoagulant such as heparin or sodium citrate. Samples can be stored at temperature 2 to 8°C and tested within 5 days without interfering with the assay performance. For long-term storage of the samples, store it at -20°C or colder is recommended. Repeated freezing and thawing of specimens is not recommended as it may cause erroneous results. Samples with cloud or precipitation should be centrifuged or filtered before testing. Prevent the serum from bacterial contamination during the collection and storage.

TEST PROCEDURE

  1. Bring the membrane plate and samples to the room temperature 20 to 30°C before use (approximately 30 minutes).

  2. Remove the test cassette or strip from the sealed foil pouch and place the plate on a flat surface.

  3. Add 2 drops (80 -100μL) of the sample into the sample well or sample pad.

  4. Read the result between 15 to 20minutes. A strong positive sample may show results earlier.

Note: Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in the clinic not provided in the kit) into the sample well if flow migration is not observed within 30 seconds in the result window that could occur with a highly viscous specimen.

INTERPRETATION OF RESULTS

  • Positive: 2 pink lines appear in both the C and T region.

  • Negative: Only 1 pink line appears in the C region.

  • Invalid: The control line next to the test line is not visible within 20 minutes after the addition of the sample.

PERFORMANCE CHARACTERISTICS


TB IgG Rapid Test


IgG ELISA Test

Positive

Negative

Total

Positive

348

0

348

Negative

2

675

677

Total

350

375

1025

Relative Sensitivity: 100%,
Relative Specificity: 99.7%,
Overall Agreement: 99.8%

LIMITATION

The testing is for qualitative and assistant diagnosis, confirmation of the infection should be referred to the clinical and other diagnosis.

PRECAUTIONS

  • Both the plate and the sample should be with room temperature 20 to 25°C.

  • Test sample must be fresh.

  • The result after 20minutes is invalid.

  • A diluted sample may generate a false positive result.

  • Bacterial contamination, serious hemolysis, jaundice, and high lipid blood can cause wrong results. The sample should be re-collected.

  • Wrong result might also be caused due to an expired kit or problematic samples.

PACKAGE : 40 tests or Kit

STORAGE AND STABILITY

Store at room temperature and the shelf life is of 24months. Do not use the kit beyond its expiry date.



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