INTENDED USE
Mycoplasma pneumoniae Antigen Rapid Test 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.
MATERIAL:
Materials provided
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Test cassettes Disposable Sampling Swab
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Assay buffer tubes Workstation
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Package Insert
Materials required but not provided
[DIRECTIONS FOR USE]
Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.
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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.
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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. 500pl) to the Extraction Tube. See illustration 1.
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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.
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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.
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Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.
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Add three drops of the solution (approx.120pl) to the sample well and then start the timer. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
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 wheneverthere 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.
Relative Sensitivity: 93.99% （95%CI: 89.45%～96.72%）
Relative Specificity: >99.99% （95%CI：98.81%～100.00%）
Accuracy: 98.06% （95%CI：96.52%～98.96%）
