【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.
【SUMMARY】
M. pneumoniae is one of three species of Mycoplasma that frequently cause infection in humans. 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.
【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.
【SAMPLE COLLECTION】
This product can be equipped with disposable sampling swabs, sampling method is as follows: Gently insert the swab head into the nasal cavity and scrape the cavity wall. Immerse the swab head into sample solution and discard the tail of swab. All specimens should be tested as soon as early they are prepared. If necessary, they may be stored at 2-8°C for up to 24 hours or at -20°C for longer periods. Restore the sample to room temperature before test.
【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.
【PRECAUTIONS】
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
【PERFORMANCE CHARACTERISTIC】
Sensitivity, Specificity and Accuracy
Dewei Rapid Test VS PCR:
Relative Sensitivity=97.06%
Relative Specificity =99.12%
Accuracy=98.15%
Precision Intra-Assay
Within-run precision has been determined by using 15 replicates off our specimens: a negative, a low positive, a middle positive and a high positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, a low positive, a middle positive and a high positive. Three different lots of the Mycoplasma pneumoniae Antigen Rapid Test have been tested using these specimens. Thespecimens were correctly identified >99% of the time.
Cross-reactivity
①Virus
No cross reaction with following pathogens: Influenza virus A(H1N1,H3N2), Influenza virus B; Adenovirus Type 1～8,11,19,37,Coxsackie virus Type A16,B1 ～ 5, Cytomegalovirus, EchovirusType3,6,9,11,14,18,30, Enterovirus Type 71, HSV-1, Mumps virus, ParainfluenzavirusType 1 ～ 3, Poliovirus Type 1 ～ 3, Respiratory syncytial virus, RhinovirusType1A,13,14.
②Mycoplasma etc.
No cross reaction with Chlamydia pneumoniae, Chlamydia psittaci, Chlamydiatrachomatis.
③Bacteria
No cross reaction with following bacteria: Acinetobacter baumannii,Bacteroides fragilis, Bordetella pertussis, Candidaalbicans,Candida glabrata, Cardiobacterium hominis ,EikeneUa corrodens, Enterococcus gallinarum.Escherichia coil, Haemophilus phrophlus, aemophilus infiuenzae, Haemophilusparainfluenzae, Haemophilus paraphrophilus, Kingella kingae, Klebsiellapneumoniae, Listeria monocytogenes, Moraxella catarrhalis, Neisseria gonorrhoeaeProteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens,Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus, pyogenes, Streptococcus agalactiae, Streptococcussp.group C, G, F, Streptococcus mutans.
For further operation or performance details, please refer to final instruction manual.
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