| 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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