giftnotes.blogg.se

Many studies have demonstrated that the potential sensitivity loss of molecular assays when pooling patient samples using traditional real-time qPCR methods for the detection of SARS-CoV-2 does not impact positive agreement, and thus patient diagnosis 5, 6, 7, 8, 9, 10, 11. Sample pooling was a relevant method to increase testing capacity while conserving reagents and reducing economic strain. Throughout the COVID-19 pandemic, every country experienced increased testing demands and global shortages of sampling tools and diagnostic reagents were observed. The highly conserved FilmArray RP2.1 SARS-CoV-2 targets are able to detect the recently emerged variants of concern, including B.1.1.7 (Alpha), B.1.351 (Beta), B1.617.2 (Delta), P.1 (Gamma), and Omicron B.1.1.529 4. The SARS-CoV-2 assay targets two regions within the S and M genes, has a limit of detection (LOD) of approximately 160 copies/ml, and a lack of cross-reactivity with other pathogens 3. A study by Leber et al., evaluating the FilmArray RP2 panel was done by analyzing 1612 clinical samples, subsequently generating 33,843 test results, and demonstrated acceptable positive and negative percent agreements, 99.2% and 99.3%, respectively 2. The FilmArray RP2.1 builds upon the former FilmArray RP2 with the addition of a SARS-CoV-2 test. Using a nasopharyngeal swab sample in 3 ml of transport media, the FilmArray Respiratory Panel (RP) 2.1 targets 22 viral and bacterial pathogens known to cause respiratory illness, including SARS-CoV-2 and influenza viruses. It is a fully automated system coupling a nucleic acid extraction and purification process with a multiplexed reverse-transcription nested PCR reaction. The BioFire FilmArray diagnostic system provides users with a rapid, easy to use testing approach, allowing laboratory workers that may not normally be able to conduct nucleic acid amplification tests (NAAT), to do so in a safer manner. This initiative focused on the distribution of multiple different platforms, which included the BioFire FilmArray diagnostic system as ways to support increased testing capacity. To alleviate this burden, the Public Health Agency of Canada supported a Northern, Remote, and Isolated Communities Initiative, as recommended by the Canadian Public Health Laboratory Network, to support building capacity in remote laboratories through provision of testing supplies and training. Increasing testing demands compounded this issue across all urban centres during the pandemic. Historically, in Canada, remote and isolated communities experience delayed access to test results attributed to specimen transport time to urban centres. The surge of cases worldwide has made it necessary for countries to increase their testing capacity, by equipping new facilities with appropriate equipment, test reagents, and training staff on appropriate handling measures. On March 11, 2020, the World Health Organization declared a Coronavirus Disease 2019 (COVID-19) pandemic and as of February 20, 2022, there have been over 422 million cases and 5.9 million reported deaths worldwide 1. Overall, this study provides evidence supporting the use of pooling patient specimens, one in four with the FilmArray Respiratory Panel 2.1 for the detection of SARS-CoV-2 and influenza virus.Ī novel coronavirus, later termed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in late December 2019, when reports of several cases of pneumonia of unknown origin were reported from China.

While discordant results were mainly attributed to loss in sensitivity, the sensitivity of the pooling assay was well within accepted limits of detection for a nucleic acid amplification test.

We observed 100% detection and 90% positive agreement for SARS-CoV-2 and 98% detection and 95% positive agreement for influenza viruses with pools of contrived or clinical specimens, respectively. This study evaluates the FilmArray Respiratory Panel 2.1 using 33 pools of contrived nasal samples and 22 pools of clinical nasopharyngeal specimens to determine the feasibility of increasing testing capacity, while maintaining detection of both SARS-CoV-2 and influenza virus. While each panel provides a robust output of information regarding pathogen detection, the specimen throughput is low. The FilmArray Respiratory Panel 2.1 targets 22 viral and bacterial pathogens, including SARS-CoV-2 and influenza virus. The BioFire FilmArray is a fully automated nucleic acid amplification test system providing specificity and sensitivity associated with gold standard molecular methods. The COVID-19 pandemic required increased testing capacity, enabling rapid case identification and effective contract tracing to reduce transmission of disease.