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Mycoplasma Pneumoniae Antigen Test Lateral Flow Immunochromatographic Assay Test

China Mycoplasma Pneumoniae Antigen Test Lateral Flow Immunochromatographic Assay Test

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Mycoplasma Pneumoniae Antigen Test Lateral Flow Immunochromatographic Assay Test

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Supply Ability	10 M tests/month
Delivery Time	2-4 Weeks
Packaging Details	20 T
Product	Mycoplasma Pneumoniae Antigen Lateral Flow Immunochromatographic Assays Rapid Test
Cat. No.	IMP-502
Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	Swab
Certificate	CE
Reading Time	15 minutes
Pack	20 T
Storage Temperature	2-30°C
Shelf Life	2 Years
Brand Name	Citest
Model Number	IMP-502
Certification	CE
Place of Origin	-

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Product Specification


Supply Ability	10 M tests/month	Delivery Time	2-4 Weeks
Packaging Details	20 T	Product	Mycoplasma Pneumoniae Antigen Lateral Flow Immunochromatographic Assays Rapid Test
Cat. No.	IMP-502	Principle	Chromatographic Immunoassay
Format	Cassette	Specimen	Swab
Certificate	CE	Reading Time	15 minutes
Pack	20 T	Storage Temperature	2-30°C
Shelf Life	2 Years	Brand Name	Citest
Model Number	IMP-502	Certification	CE
Place of Origin	-
High Light	Mycoplasma Pneumoniae Antigen Test ，Lateral Flow Immunochromatographic Assay Test ，Immunochromatographic Assay Test Kit

Product features	Parameters
Principle	Chromatographic Immunoassay
Format	Cassette
Specimen	Swab
Certificate	CE
Reading Time	15 minutes
Pack	20 T
Storage Temperature	2-30°C
Shelf Life	2 Years

Mycoplasma Pneumoniae Antigen Lateral Flow Immunochromatographic Assays Rapid Test

A rapid test for the qualitative detection of Mycoplasma pneumoniae Antigen in throat swab. For professional in vitro diagnostic use only.

INTENDED USE

Mycoplasma pneumoniae Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Mycoplasma pneumoniae(M. pneumoniae) antigens in human throat swabs. It is intended to aid in the rapid differential diagnosis of Mycoplasma pneumoniae infections.

SUMMARY

M. pneumoniae is one of three species of Mycoplasma that frequently cause infection in humans.1 M. pneumoniae most commonly causes upper respiratory tract infections, but can also cause pneumonia. The identification of the M. pneumoniae will help the administration of the disease with appropriate antibiotic treatment. This M. pneumoniae immunoassay is intended to detect M. pneumoniae antigen qualitatively. Because this one-step M. pneumoniae rapid test is easy to carry out, it is widely used as a screening test device and as an aid in the diagnostics of M. pneumoniae disease.

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.

DIRECTIONS FOR USE

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution (Approx. 500μl) to the Extraction Tube. See illustration 1.

3. Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.

4. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.

5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.

6. Add three drops of the solution (approx.120μl) to the sample well and then start the timer. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

RESULT INTERPRETATION

POSITIVE: Two colored lines appear. One colored line appears in the control region(C), and one colored line in the test region(T). The shade of color may vary,but it should be considered positive whenever there is even a faint line.

NEGATIVE: Only one colored line appears in the control region(C), and no line in the test region(T). The negative result indicates that there are no M. pneumoniae in the sample or the number of M. pneumoniae is below the detectable range.

INVALID: No line appears in the control region(C). The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Cat. No.	Product	Specimen	Pack
IMP-502	Mycoplasma pneumoniae Antigen Rapid Test Cassette	Swab	20T

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CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies. ... CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies. ...

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CITEST DIAGNOSTICS INC.
170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
https://www.citesttestkit.com/

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