(240 days)
The NucliSENS EasyQ® MRSA assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization. The NucliSENS EasyQ® MRSA assay is performed on the NucliSENS EasyQ® platform.
The test utilizes NASBA™ (nucleic acid sequence-based amplification) coupled with molecular beacons (sequence-specific fluorescent probes) to detect the presence of MRSA DNA.
The NucliSENS EasyQ® MRSA assay is used as a screening tool to aid in the prevention and control of MRSA infections in health care institutions.
NucliSENS EasyQ® MRSA is not intended to diagnose, quide or monitor treatment for MRSA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
The NucliSENS EasyQ® MRSA assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs. The test utilizes NASBA™ (nucleic acid sequence-based amplification) coupled with molecular beacons (sequence-specific fluorescent probes) to detect the presence of MRSA DNA. The assay is performed on the NucliSENS EasyQ® platform, which includes the NucliSENS EasyQ® Analyzer, NucliSENS EasyQ® Incubator II, NucliSENS EasyQ® Computer, Monitor, Printer, and NucliSENS EasyQ® Director Software 2.6. The assay involves manual specimen processing from a dry flocked nasal swab, followed by automated amplification and detection in a closed tube format. Result calculation is performed automatically via dedicated operator software based on the analysis of fluorescence signal curves. Qualitative output (MRSA positive, MRSA negative or invalid) is reported to users. The assay includes an inhibition control and run controls (blank and positive control). Specimen preparation controls are recommended but not provided in the kit.
Acceptance Criteria and Device Performance for NucliSENS EasyQ® MRSA Assay
1. Table of Acceptance Criteria and Reported Device Performance
The submission document primarily reports the performance metrics rather than explicitly stating pre-defined acceptance criteria with specific threshold values for each. However, based on the statistical results and the general context of medical device submissions, we can infer the implied acceptance criteria.
| Performance Metric | Implied/Inferred Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Clinical Sensitivity (Overall) | High (e.g., >90%) | 95.8% (91.1-98.4% CI) |
| Clinical Specificity (Overall) | High (e.g., >90%) | 96.8% (95.5-97.7% CI) |
| Positive Predictive Value (PPV) (Overall) | Adequate, considering prevalence (e.g., >70% or >75% at typical prevalence) | 79.7% (72.9-85.4% CI) |
| Negative Predictive Value (NPV) (Overall) | Very High (e.g., >98%) | 99.4% (98.8-99.8% CI) |
| Clinical Sensitivity (Adults) | High (e.g., >90%) | 94.7% (88.8-98.0% CI) |
| Clinical Specificity (Adults) | High (e.g., >90%) | 96.5% (95.0-97.7% CI) |
| Clinical Sensitivity (Pediatrics) | High (e.g., >90%) | 100% (88.4-100% CI) |
| Clinical Specificity (Pediatrics) | High (e.g., >90%) | 97.3% (94.9-98.8% CI) |
| Initial Invalid Result Rate | Low (e.g., |
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).