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Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit

Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit
Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit
Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit Tuberculosis TB Rapid Test Kit Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit
Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO, CE
Model Number: TB-DW22
Minimum Order Quantity: 3000 units
Price: Negotiable
Packaging Details: 25test/box, 40test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Get Best Price Contact Now
Detail Information
Sample: Whole Blood/Serum/Plasma Type: Cassette
Certificate: ISO, CE Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Tuberculosis TB Rapid Test Kit

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Tuberculosis Rapid Diagnostic Test Kit

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TB Rapid Diagnostic Test Kit

Product Description

Tuberculosis (TB) Rapid Test Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit

For professional use only.
For in vitro diagnostic use only.
 

【INTENDED USE】

The Tuberculosis (TB) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of Tuberculosis.

 

 

 

【INTRODUCTION】
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.

 

 

 

【PRINCIPLE】
The Tuberculosis (TB) Rapid Test detects anti-TB antibodies through visual interpretation of color development on the internal strip. TB antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with TB antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to TB in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

 

 

 

【MAIN CONTENTS】
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
 
 
 
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
 
 

 

【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
 
 

 

【SAMPLE COLLECTION】
• The Tuberculosis (TB) Rapid Test is intended for use with human whole blood, serum, or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
 

 

 

【DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 1 drop of whole blood/serum/plasma into the sample well (S), then add 1 drop of Buffer, and start the timer.
Avoid trapping air bubbles in the specimen well, and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Donot interpret after 20 minutes.

 

 

 
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
 
 
 
 

For further operation or performance details, please refer to final instruction manual.

 

 

 

 

Tag:

Rapid Test Kit,

POCT,

Rapid Diagnostic Test

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708

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