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.
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.
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.
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.
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.
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.
|Mycoplasma pneumoniae Antigen Rapid Test Cassette