A Semi-Quantitative and Quantitative Multiplex Nucleic Acid Detection System for MERS-CoV (Middle East Respiratory Syndrome Coronavirus) and Common Respiratory Pathogens refers to a diagnostic method designed to detect multiple pathogens simultaneously in a single sample. It combines both semi-quantitative and quantitative analysis of nucleic acids (such as RNA or DNA) to identify the presence of viruses and bacteria responsible for respiratory infections.

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, in accordance with the guidelines provided by the appropriate public health authorities.

Intended Use:

The system is a multiplexed nucleic acid test intended  for the simultaneous detection and identification of nucleic acids from Middle East respiratory syndrome coronavirus (MERS- CoV) and multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals meeting MERS-CoV clinical and/or epidemiological criteria.

Device Description:

The device is a molecular multiplex respiratory pathogen panel that combines sample preparation, nucleic acid amplification (e.g., PCR), target detection, and result interpretation in an integrated workflow designed to operate with a dedicated analytical instrument and software.

Key Device Components

• Reagent Cartridge or Test Panel
• Analyzer Instrument
• Software Module
• Controls

Operation

A clinical respiratory specimen (e.g., induced sputum, expectorated sputum, endotracheal aspirate, or BAL/mini-BAL fluid) is mixed with provided buffers and loaded into the reagent cartridge. The cartridge is run on the analyzer, which automatically performs:

• Nucleic Acid Extraction
• Multiplex Amplification
• Detection
• Interpretation: Software interprets signals and reports each pathogen target as detected/not detected; bacterial targets may be reported in semi-quantitative bins to aid clinical interpretation.

Performance Testing (Analytical Nonclinical) for Mers-Cov and Common Respiratory Pathogens Semi-Quantitative and Quantitative Multiplex Nucleic Acid Detection System

• precision/Reproducibility
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Interference
• Analytical Sensitivity
• Software verification and Validation

Clinical Testing:

Required for 510 submissions.