Newscen Biopharm Co., Limited
Professional Manufacturer of Rapid Test Devices
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TB (Tuberculosis) Rapid Test Kit
For the Qualitative Detection of Antibody against Tuberculosis in serum and plasma
Main Features
♦ High Sensitivity
♦ Specificity
♦ Reliable: high accurate, early detection of the presence of TB
♦ Simple: No Instrument Required
♦ Convenient: Room Temperature Storage, Built-In Control line
♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
♦ Certified by Authoritative Certification System and Standards
♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
Summary
Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) is a membrane-based screening test for the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti-Mycobacterium Tuberculosis in human whole blood, serum or plasma.
This innovative rapid screening test is based on lateral flow immunochromatography and is among the easiest point of care (POC) assay diagnostics.
The Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)is suitable to test for antibodies in whole blood, serum or plasma. It is for professional in vitro diagnostic use only.
Main Specifications
| Function | For the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti- Mycobacterium Tuberculosis in human whole blood, serum or plasma. |
| Formats | cassette |
| Size | cassette(3mm, 4mm) or according to the customers' requirements |
| Specimens | whole Blood/Serum/Plasma |
| Specificity | over 99% |
| Reaction Time | 10 minutes |
| Shelf Life | 24 months at room temperature 4- 30 degrees |
| Packing Details | Cassette 40pcs/bag, 50bags/carton. 500,000pcs/20'ft container 40pcs/box, 50boxes/carton, 550,000pcs/20’ft container 1pcs/box, 500boxes/carton, 120,000pcs/20’ft container 100pcs/bag, 100bags/carton .1,300,000pcs/20'ft container 100pcs/box, 50boxes/carton, 1,700,000pcs/20’ft container 50pcs/box, 100boxes/carton, 1,600,000pcs/20’ft container 1pcs/box, 500boxes/carton, 120,000pcs/20’ft container |
| Others | The kits can be made according to the customers' artwork or design |
Materials Supplied
☀Test Cassette
☀ Pipette Dropper
☀ Desiccant
☀ Buffer
☀ Package Insert
Material Required But Not Provided
☀ Clock or Timer
☀ Specimen collection containers.
☀ Timer
☀ Lancets (for fingerstick whole blood only)
☀ Centrifuge (for plasma only)
Interpretation of Results
☀ Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no TB antibody has been detected.
☀ Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains TB.
☀ Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.
Warnings and Precautions
☀ For professional In Vitro diagnostic use only.
☀ Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to prevent azide build-up.
☀ Do not use it if the tube pouch is damaged or broken.
☀ Test is for single use only. Do not re-use under any circumstances.
☀ Handle all specimens as if they contain infectious agents. Observe established standard procedure for 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.
Storage and Stability
All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C.
If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.