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Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE

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Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE

China Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE supplier
Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE supplier Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE supplier

Large Image :  Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Price: USD0.1-USD1
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 10000000pcs/month
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Detailed Product Description
Category: Infectious Format: Cassette
Specimen: Whole Blood/Serum/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: TB Test
Accuracy: 89.65%

Infectious Tuberculosis Disease Blood Test, gold colloidal method, professional screen test use, 4mm cassette


One Step TB Rapid Diagnostic Test Cassette

 

 

Product Cat No Specimen Sensitivity Format Kit Size
TB Ab YI002C4 Serum/Plasma See Insert 4mm Cassette 25T

 

Intended Use:

The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens.

 

 

Summary:

 

 

Tuberculosis (TB) is spread primarily via airborne transmission of aerosolized droplets developed by coughing, sneezing and talking. Areas of poor ventilation pose the greatest risk of exposure to infection. TB is a major cause of morbidity and mortality worldwide, resulting in the greatest number of deaths due to a single infectious agent. The World Health Organization reports that more than 8 million new cases of active tuberculosis are diagnosed annually. Almost 3 million deaths are attributed to TB as well. Timely diagnosis is crucial to TB control, as it provides early initiation of therapy and limits further spread of infection. Several diagnostic methods for detecting TB have been used over the years including skin test, sputum smear, and sputum culture and chest x-ray. But all these methods have some limitations. Newer tests, such as PCR-DNA amplification or interferon-gamma assay, have been recently introduced. However, the turn-around time for these tests is long, they require laboratory equipment and skilled personnel, and some are neither cost effective nor easy to use. These tests are also expensive and not practical for developing countries. Serological methods constitute an attractive alternative, since TB serodiagnosis is simple, inexpensive, relatively non-invasive, and it does not depend on detection of mycobacteria. The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test for qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens. The test utilizes a combination of recombinant antigens to detect elevated levels of anti-TB antibodies in whole blood, serum or plasma specimens.

 

 

TEST PRINCIPLE

 

The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, solid phase, two-site sandwich immunoassay for the detection of anti-TB antibodies in whole blood, serum or plasma specimens. The membrane is pre-coated with TB recombinant antigen on the test line region of the Cassette. During testing, the anti-TB antibodies, if present in whole blood, serum or plasma specimen react with the particles coated with TB recombinant antigen. The mixture migrates upward on the membrane chromatographically by capillary action to react with TB recombinant antigen on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred

 

 

TEST PROCEDURE

 

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

 

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE

 

Tuberculosis Infectious Disease Blood Tests 4mm Cassette Serum Specimens CE

 

 

INTERPRETATION OF RESULTS

 

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

 

Negative:

The control line appears in the result window, but the test line is not visible.

 

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

 

Clinical Performance

 

A total of 200 specimens from the non-TB patients and 35 specimens from the patients under anti TB treatment were tested by the TB Rapid Test and a commercial TB ELISA kit. Comparison for all subjects is showed in the following table.

 

  TB Rapid Test  
IgM ELISA Test Positive Negative Total
Positive 30 5 35
Negative 7 193 200
Total 37 198 235

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

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