TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: RESPM    
Respiratory Pathogen Panel, PCR, Nasopharyngeal

Method Description Describes how the test is performed and provides a method-specific reference

The FilmArray Respiratory Panel is a closed system that performs all the chemistry required to isolate, amplify, and detect nucleic acid from multiple viral and bacterial respiratory pathogens within a single nasopharyngeal swab specimen. The panel contains reagents in freeze-dried form and is divided into discrete segments where the required chemical processes are carried out. Patient sample and hydration fluid are drawn by vacuum into the panel and then placed into the FilmArray instrument. The detection process operations are automated (nucleic acid purification, first stage PCR, second stage PCR, and melt analysis) and complete in about 45 minutes in this closed system:

 

Nucleic Acid Purification: The sample is lysed by a combination of chemical and mechanical mechanisms and the liberated nucleic acid is captured, washed and eluted using magnetic bead technology.

 

First-Stage PCR: A reverse transcription step is performed to convert viral RNA into cDNA prior to amplification. The purified nucleic acid solution is combined with a preheated master mix to initiate the reverse transcription step and subsequent thermo cycling for multiplex PCR.

 

Second-Stage PCR: Products of first stage PCR are diluted and mixed with fresh PCR reagents, which is distributed over the second stage PCR array. The individual wells of the array contain primers for different assays (in triplicate) that target specific nucleic acid sequences from each of the pathogens detected, as well as control template material.

 

DNA Melting Analysis: Temperature is slowly increased and fluorescence in each well of the array is monitored and analyzed to generate a melt curve.

 

Analysis of Melt Curves: The software evaluates the DNA melt curve for each well to determine if a PCR product was present in that well. If the melt profile indicates the presence of a PCR product, then the analysis software calculates the melting temperature of the curve, which is then compared against the expected range for the assay. When the software determines that the melt curve falls inside the assay-specific melt temp range, it is called positive. When it determines that the melt curve is not in the appropriate range, it is called negative.

 

Analysis of Replicates: Melt curves of each of the 3 replicates for each assay are evaluated to determine the assay result. For an assay to be called positive, at least 2 of the 3 associated melt curves must be called positive, and the melting temperature (Tm) for at least 2 of the 3 positive melt curves must be similar (within 1 degree C). Assays that do not meet these criteria are called negative.(Instruction booklet: FilmArray Respiratory Panel 2 (RP2) CE IVD, BioFire Diagnostics, LLC., Salt Lake City, Utah. RFIT-PRT-0522-01 06/2017)

PDF Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Sunday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Clinic Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location Indicates the location of the laboratory that performs the test

Rochester