| Customization: | Available |
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| Type: | IVD Reagent |
| Specimen: | Serum or Plasma |
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INTENDED USE
Mycoplasma pneumoniae Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Mycoplasma pneumoniae(M. pneumoniae) antigens in human nasopharyngeal swabs. It is intended to aid in the rapid differential diagnosis of Mycoplasma pneumoniae infections.
PRINCIPLE
The Mycoplasma pneumoniae Antigen Rapid Test Cassette a qualitative, lateral flow immunoassay for the detection of M. pneumoniae antigen in a throat swab. In this test, antibody specific to M. pneumoniae antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to M. pneumoniae that is coated onto particles. The mixture migrates up the membrane to react with the antibody to M. pneumoniae on the membrane and generate a color line in the test line region. The presence of this color line in the test line 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.
MAIN CONTENTS
• Rapid Test Cassette.
• Extraction buffer and tube.
• Swab.
• Instructions for use
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
DIRECTION OF USE
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Insert the tip onto tube membrane, take out the tip after membrane's puncture.
2. Collect the swab sample according to above instruction.
3. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube. Leave the swab into the extraction tube for 1 minute. Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
4. Put the tip onto the tube, and take out its cap.
5. Add 2 drops of the mixed sample to each sample wells of the cassette and read the results in 15 minutes. Do not 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.
PERFORMANCE CHARACTERISTIC
Sensitivity, Specificity and Accuracy
Dewei Rapid Test VS PCR:
Relative Sensitivity=97.06%
Relative Specificity =99.12%
Accuracy=98.15%
For further operation or performance details, please refer to final instruction manual.
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.
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