Laboratory diagnostic test that can simultaneously detect and quantify the genetic material (nucleic acid) of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) alongside a range of other common respiratory pathogens, allowing for a comprehensive analysis of potential causes of respiratory illness in a single test, with the ability to estimate the relative abundance of each detected pathogen through semi-quantitative or quantitative.

Intended Use of MERS-CoV and Common Respiratory Pathogens Semi-Quantitative and Quantitative Multiplex Nucleic Acid Detection System

A Middle East Respiratory Syndrome Coronavirus (MERS-Cov) And Common Respiratory Pathogens Qualitative, Semi-Quantitative or Quantitative Multiplex Nucleic Acid Detection System is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data.

Intended Use:

A multiplexed nucleic acid test used to detect and identify nucleic acids from Middle East respiratory syndrome coronavirus (MERS-CoV), multiple respiratory viral and bacterial nucleic acids, and select antimicrobial resistance genes in sputum-like or bronchoalveolar lavage specimens. Testing should only be performed if the patient meets clinical or epidemiologic criteria for suspected                  MERS-CoV specimens.

Device description:

The Panel pouch is used for specimen testing and analysis. It contains freeze-dried reagents, rehydrated with Hydration Solution and Sample Buffer Mix. The software guides the user through the process. The instrument uses inflatable bladders and seal points to control liquid movement between blisters. Electronically controlled pneumatic pistons deliver rehydrated reagents at the right times. Peltier devices control the pouch’s heating and cooling for PCR reactions and melt curve analysis.

Performance Testing (Analytical Non-Clinical) for MERS-CoV and Common Respiratory Pathogens Semi-Quantitative and Quantitative Multiplex Nucleic Acid Detection System

• Stability Studies
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances
• Prozone effect study

Clinical Testing.

No Guidance available for 510k submission