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Global Healthcare Medical
GHM Mycoplasma pneumoniae Antigen Rapid Test US – Qualitative Detection of Mycoplasma pneumoniae Antigen with 15-Minute Results, Throat Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Mycoplasma pneumoniae Antigen Rapid Test US – Qualitative Detection of Mycoplasma pneumoniae Antigen with 15-Minute Results, Throat Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Mycoplasma pneumoniae Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Mycoplasma pneumoniae Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Mycoplasma pneumoniae antigen directly from human throat swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of active Mycoplasma pneumoniae respiratory infection in symptomatic individuals.
Mycoplasma pneumoniae is one of the major causative pathogens of atypical pneumonia and can cause severe pneumonia in certain instances. The number of antibiotics that can be used is limited, and early differential diagnosis to rule out typical bacterial pneumonia is recommended for initiating appropriate antibiotic treatment as soon as possible. M. pneumoniae is a common cause of respiratory infections in school-age children, with waves of increased prevalence every few years. During the COVID-19 pandemic, M. pneumoniae infections decreased globally; however, cases increased in all age groups in 2024, with a significant post-pandemic resurgence observed in multiple regions worldwide. A recent study reported an increase from only 2 positive patients between January and April 2023 to 82 positive patients during the same period in 2024 at a single pediatric center. By targeting bacterial antigens rather than antibodies, the test enables early detection without the need to wait for seroconversion, making it particularly useful during the acute phase of disease when antibody-based assays may still yield negative results.
The GHM Mycoplasma pneumoniae Antigen Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human throat swab specimens, providing a simple and efficient sample collection method suitable for a wide range of clinical settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including pediatric clinics, physician office laboratories, urgent care centers, hospital laboratories, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.
Key Features & Benefits
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM Mycoplasma pneumoniae Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a double antibody sandwich method. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to the Mycoplasma pneumoniae antigen, along with immobilized capture antibodies on the test line. During testing, the extracted throat swab specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if Mycoplasma pneumoniae antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Double antibody sandwich method | Targeted detection of Mycoplasma pneumoniae antigen |
| M. pneumoniae-specific monoclonal antibodies | Specific and accurate detection |
| Qualitative visual result | Clear and interpretable test outcome |
| No special equipment required | Simple and efficient testing workflow |
Fast Results – 15 Minutes
The GHM Mycoplasma pneumoniae Antigen Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for pediatric clinics and physician offices |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Throat Swab Sample Compatibility – Simple and Efficient Collection
The GHM Mycoplasma pneumoniae Antigen Rapid Test US is compatible with human throat swab specimens, providing a simple and efficient sample collection method. The test is compatible with fresh respiratory specimens collected using sterile swabs.
| Feature | Benefit |
|---|---|
| Throat swab specimen | Simple and efficient sample collection |
| Compatible with standard sterile swabs | No special collection equipment required |
| No special equipment required | Streamlined workflow in clinical settings |
| Patient-friendly | Comfortable sample collection experience |
Clinical Utility – Aid for Diagnosis of Mycoplasma pneumoniae Infection
The GHM Mycoplasma pneumoniae Antigen Rapid Test US is intended for use as an aid in the diagnosis of active Mycoplasma pneumoniae respiratory infection. Antigen testing is most effective during the acute stage of respiratory illness, when symptoms often resemble the common cold or other atypical pneumonias. The test provides rapid etiological diagnosis, enabling timely initiation of appropriate antimicrobial therapy and supporting antibiotic stewardship efforts.
The test is particularly valuable for pediatric and young adult patient populations, where Mycoplasma pneumoniae respiratory infections are more prevalent and can be clinically severe. Early confirmation of atypical pneumonia supports timely initiation of appropriate therapy and assists in the differential diagnosis of respiratory infections, reducing reliance on delayed serological testing.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current M. pneumoniae infection |
| Early symptomatic phase utility | Optimized for the acute phase of respiratory infection |
| Differential diagnosis support | Helps distinguish M. pneumoniae from bacterial and viral causes |
| Antibiotic treatment support | Enables timely initiation of appropriate antimicrobial therapy |
| Antibiotic stewardship support | Helps reduce unnecessary broad-spectrum antibiotic use |
| Pediatric relevance | Particularly useful in pediatric clinical settings |
| Clinical versatility | Useful across pediatric clinics, physician offices, and emergency settings |
High Accuracy – Trusted Clinical Performance
The GHM Mycoplasma pneumoniae Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The test is validated against PCR methods and demonstrates high reliability for rapid respiratory diagnostics.
| Parameter | Specification |
|---|---|
| Sensitivity | 96.6% |
| Specificity | 97.7% |
| Accuracy | 97.2% |
| Limit of Detection | 7.81 × 10³ CFU/mL |
| Cross-reactivity | No cross-reactivity observed with a broad panel of respiratory bacteria, viruses (including Influenza A/B, RSV, Adenovirus), or other Mycoplasma and Chlamydia species |
ISO 13485 Certified – Quality and Safety Compliance
The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| IVD scope | Certified for in vitro diagnostic test kits |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
CE Marked – European Conformity
The GHM Mycoplasma pneumoniae Antigen Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.
| Feature | Benefit |
|---|---|
| CE marking | Regulatory compliance for professional use |
| Professional IVD use | Designed for trained healthcare personnel |
| Quality compliance | Meets European regulatory standards |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM Mycoplasma pneumoniae Antigen Rapid Test US |
| Product Code | MP-502b |
| Product Type | Mycoplasma pneumoniae Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Mycoplasma pneumoniae antigen directly from human throat swab specimens; used as an aid in the diagnosis of active Mycoplasma pneumoniae respiratory infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold double antibody sandwich immunoassay |
| Target Antigen | Mycoplasma pneumoniae antigen |
| Specimen | Throat swab |
| Time to Result | 15 minutes |
| Sensitivity | 96.6% |
| Specificity | 97.7% |
| Accuracy | 97.2% |
| Limit of Detection | 7.81 × 10³ CFU/mL |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | Pediatric clinic, physician office laboratory, urgent care center, hospital laboratory, clinical laboratory, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Sizes | 20 tests/kit |
| Kit Contents | Mycoplasma pneumoniae Rapid Antigen Test Cassette, Extraction Tubes with Buffer, Sterile Throat Swabs, Nozzles with Filter, Tube Stand, Package Insert with Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Mycoplasma pneumoniae Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Throat swab compatibility | Simple and efficient sample collection |
| Mycoplasma pneumoniae-specific detection | Targeted detection of M. pneumoniae antigen |
| High sensitivity and specificity | 96.6% sensitivity and 97.7% specificity |
| PCR-validated performance | Validated against PCR methods for high reliability |
| No cross-reactivity | No cross-reactivity with other respiratory pathogens |
| Antibiotic stewardship support | Supports timely initiation of appropriate antimicrobial therapy |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for pediatric clinics, physician offices, and emergency departments |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Mycoplasma pneumoniae Antigen Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
