(50 days)
The BD GeneOhm™ MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD GeneOhm™ MRSA ACP Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
The BD GeneOhm™ MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs. A nasal specimen is collected and transported to the laboratory using a recommended swab. The lysis of bacterial cells in nasal swab specimens is performed using the BD GeneOhm™ MRSA ACP Lysis kit. An aliquot of the lysate is added to prepared PCR reagents which contain MRSA-specific primers that will amplify in the presence of genetic target. The assay also includes an Internal Control (IC) to monitor for the presence of inhibitors in the PCR reaction and to confirm the integrity of assay reagents. Controls and specimen lysates are added to disposable reaction tubes and placed in the SmartCycler® II instrument. The amplification, detection and results interpretation are automatically performed by the SmartCycler® II software. The BD GeneOhm™ MRSA ACP Assay procedure can be performed within 2 hours, depending on the number of specimens processed. To recover MRSA for epidemiological typing or for further antibiotic susceptibility testing, appropriate culture media can be inoculated during or up to 24 hours after specimen preparation. The primers and probes in the BD GeneOhm™ MRSA ACP Assay detect a proprietary sequence inserted into the S. aureus chromosome indicating the presence of MRSA DNA. Amplification of IC and MRSA DNA are detected using specific hybridization probes that bind to a specific sequence of the amplified target. Differentiation of MRSA DNA and IC is done using molecular beacons which contain different fluorometric properties. The beacon-target hybrid fluoresces at a different wavelength for MRSA and IC and the emitted light from this reaction is measured by the SmartCycler® II instrument. MRSA or IC specific amplicons are detected simultaneously in two different fluorescence channels on the SmartCycler and can therefore be differentiated. The operation of the SmartCycler® II instrument is based on the proprietary microprocessor-controlled I-CORE® (Intelligent Cooling/Heating Optical Reaction) module.
Here's a summary of the acceptance criteria and the study that proves the device (BD GeneOhm™ MRSA ACP Assay) meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of values. Instead, it presents performance data from a clinical trial and analytical studies. Here, I've inferred the implied acceptance criteria based on the reported results and typical expectations for such devices. The "reported performance" column directly quotes or summarizes the study findings.
| Category | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | High sensitivity expected for detecting MRSA in nasal swabs to aid in prevention/control. (e.g., >85-90%) | Overall Sensitivity: 92.0% (95% CI: 87.1%, 95.4%) |
| Site 1: 94.0% (85.4%, 98.3%) | ||
| Site 2: 88.9% (77.4%, 95.8%) | ||
| Site 3: 92.4% (83.2%, 97.5%) | ||
| Specificity | High specificity expected to minimize false positives, particularly given its use in infection control. (e.g., >90-95%) | Overall Specificity: 94.6% (95% CI: 93%, 95.9%) |
| Site 1: 96.7% (94.7%, 98.1%) | ||
| Site 2: 89.8% (85.4%, 93.2%) | ||
| Site 3: 95.1% (91.7%, 97.3%) | ||
| Unresolved Rate | Low unresolved rate, ideally 95% inclusivity). | 99% of 140 diverse MRSA strains detected when tested at 100 genome copies/µL. All tested MREJ wild types and mutant types, SCCmec types I-VI, PFGE types USA 100-1100, VRSA, and VISA were detected. 83% detected in all triplicate tests at |
§ 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).