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The EZER™ Mycoplasma pneumoniae Antigen Rapid Test is a chromatographic lateral flow immunoassay for the qualitative detection of Mycoplasma pneumoniae antigens in human throat swab samples. Intended for rapid differential diagnosis, this assay helps identify M. pneumoniae infections during the acute stage of respiratory illness, when symptoms often resemble the common cold or other atypical pneumoniaes.
By targeting bacterial antigens rather than antibodies, the test enables early detection without the need to wait for seroconversion. It can be used as a frontline diagnostic tool in clinical laboratories, outpatient clinics, and respiratory screening settings. With a read time of 15 minutes and an overall agreement of 97.2%, it provides dependable results to guide patient management and treatment decisions.
The kit contains all necessary components for testing, including sterile swabs, extraction buffer, and cassette-based devices. Test results are interpreted visually through red control (C) and test (T) lines. A positive result confirms the presence of M. pneumoniae antigen in the specimen. The test demonstrates 96.6% sensitivity and 97.7% specificity, making it a reliable solution for rapid respiratory pathogen detection
Each kit contains:
20 EZER™ Mycoplasma pneumoniae test cassettes
20 sterile throat swabs
20 extraction tubes with buffer
20 nozzles
1 tube stand
1 package insert with instructions
The test detects Mycoplasma pneumoniae antigen through immunochromatographic analysis. If antigen is present in the sample, a red line appears in the test region (T) along with the control (C) line.
Mycoplasma pneumoniae is a common respiratory pathogen and a major cause of atypical pneumonia. It lacks a cell wall and frequently causes infections that are clinically indistinguishable from viral respiratory illnesses, often leading to delayed diagnosis. Detection of M. pneumoniae antigen:
Supports early confirmation of atypical pneumonia
Enables timely initiation of appropriate therapy
Assists in differential diagnosis of respiratory infections
Reduces reliance on delayed serological testing
Because antigen detection reflects active infection, this test is particularly useful during the acute phase of disease, when antibody-based assays may still yield negative results.
This test is developed by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. and utilizes highly selective monoclonal antibodies specific to M. pneumoniae, conjugated for visual detection in a lateral flow format.
Performance Summary:
Sensitivity: 96.6%
Specificity: 97.7%
Overall Agreement: 97.2%
Time to Result: 15 minutes
Limit of Detection: 7.81 × 10³ CFU/mL
No cross-reactivity was observed with a broad panel of respiratory bacteria, viruses (including Influenza A/B, RSV, Adenovirus), or other Mycoplasma and Chlamydia species. The test is validated against PCR methods and demonstrates high reliability for rapid respiratory diagnostics.
Sample Type:
Throat swab
Test Procedure:
Collect throat swab specimen using the sterile swab provided
Extract sample in buffer using the extraction tube
Add 3 drops of extracted sample to the cassette
Read result at 15 minutes
Result Interpretation:
Positive: Two red lines (C and T)
Negative: One red line (C only)
Invalid: No control line — retest required
The simple workflow and visual readout make the test suitable for both clinical and near-patient testing environments.
The EZER™ Mycoplasma pneumoniae Antigen Rapid Test is intended for:
Rapid diagnosis of atypical pneumonia
Differential diagnosis of acute respiratory infections
Use in outpatient clinics and hospitals
Support of respiratory disease management in pediatric and adult populations
With its fast turnaround and reliable antigen detection, the test helps clinicians initiate appropriate treatment earlier and improve patient outcomes in respiratory care settings.
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