Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2
Background: Various nucleic acid amplification assays for the diagnosis of SARS-CoV-2 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real-Q 2019-nCoV as...
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Wiley Open Access
2022
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| Online Access: | https://pubmed.ncbi.nlm.nih.gov/34882825/ http://hdl.handle.net/11408/4664 |
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| author | Marembo, Takudzwa Chimbunde, Prosper Chipendo, Tendai Munemo, Clayton Manangazira, Portia Bangure, Donewell |
| author_facet | Marembo, Takudzwa Chimbunde, Prosper Chipendo, Tendai Munemo, Clayton Manangazira, Portia Bangure, Donewell |
| author_sort | Marembo, Takudzwa |
| collection | DSpace |
| description | Background: Various nucleic acid amplification assays for the diagnosis of SARS-CoV-2 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real-Q 2019-nCoV assay targeting the E and RdRP genes to DaAn Gene 2019-nCoV kit targeting the N gene and ORF1ab in the diagnosis of SARS-CoV-2.
Methods: We performed a diagnostic comparison study by testing nasopharyngeal samples for SARS-CoV-2 using the two reverse transcription polymerase chain reaction (RT-PCR) assays. Assay agreement was assessed by overall percent agreement, negative percent agreement, positive percent agreement, and Cohen's kappa coefficient.
Results: A total of 48 nasopharyngeal samples were tested using the two assays. One sample was invalid, and three showed inconclusive results with Real-Q; hence, 44 were included for the comparative analysis. Overall, percent agreement between the assays was 93.2% (95% CI 81.3%-98.6%), Positive percent agreement (PPA) was 86.4% (95% CI 65.1%-97.1%) and negative percent agreement (NPA) was 100% (95% CI 84.6%-100%). The kappa coefficient was 0.86 (95% CI 0.72-1.01). Three samples (6.8%) were positive with DaAn gene kit and negative with Real-Q. The fluorescence intensity for Real-Q reporter dyes was low.
Conclusion: The two kits showed high levels of concordance in their detection of SARS-CoV-2 despite having different gene targets. The Biosewoom kit can be improved through addressing the fluorescence intensity of the target dyes, and feedback was given to the manufacturer. |
| format | Article |
| id | ir-11408-4664 |
| institution | My University |
| language | English |
| publishDate | 2022 |
| publisher | Wiley Open Access |
| record_format | dspace |
| spelling | ir-11408-46642022-06-27T13:49:06Z Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 Marembo, Takudzwa Chimbunde, Prosper Chipendo, Tendai Munemo, Clayton Manangazira, Portia Bangure, Donewell COVID-19 PCR SARS-CoV-2 Coronavirus Zimbabwe Background: Various nucleic acid amplification assays for the diagnosis of SARS-CoV-2 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real-Q 2019-nCoV assay targeting the E and RdRP genes to DaAn Gene 2019-nCoV kit targeting the N gene and ORF1ab in the diagnosis of SARS-CoV-2. Methods: We performed a diagnostic comparison study by testing nasopharyngeal samples for SARS-CoV-2 using the two reverse transcription polymerase chain reaction (RT-PCR) assays. Assay agreement was assessed by overall percent agreement, negative percent agreement, positive percent agreement, and Cohen's kappa coefficient. Results: A total of 48 nasopharyngeal samples were tested using the two assays. One sample was invalid, and three showed inconclusive results with Real-Q; hence, 44 were included for the comparative analysis. Overall, percent agreement between the assays was 93.2% (95% CI 81.3%-98.6%), Positive percent agreement (PPA) was 86.4% (95% CI 65.1%-97.1%) and negative percent agreement (NPA) was 100% (95% CI 84.6%-100%). The kappa coefficient was 0.86 (95% CI 0.72-1.01). Three samples (6.8%) were positive with DaAn gene kit and negative with Real-Q. The fluorescence intensity for Real-Q reporter dyes was low. Conclusion: The two kits showed high levels of concordance in their detection of SARS-CoV-2 despite having different gene targets. The Biosewoom kit can be improved through addressing the fluorescence intensity of the target dyes, and feedback was given to the manufacturer. 2022-01-25T11:21:06Z 2022-01-25T11:21:06Z 2022 Article 0887-8013 1098-2825 10.1002/jcla.24161 https://pubmed.ncbi.nlm.nih.gov/34882825/ http://hdl.handle.net/11408/4664 en Journal of Clinical Laboratory Analysis;Vol. 36; No. 1 open Wiley Open Access |
| spellingShingle | COVID-19 PCR SARS-CoV-2 Coronavirus Zimbabwe Marembo, Takudzwa Chimbunde, Prosper Chipendo, Tendai Munemo, Clayton Manangazira, Portia Bangure, Donewell Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title | Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title_full | Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title_fullStr | Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title_full_unstemmed | Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title_short | Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2 |
| title_sort | comparison of real-q 2019-ncov and daan gene 2019-ncov polymerase chain reaction assays for the detection of sars-cov-2 |
| topic | COVID-19 PCR SARS-CoV-2 Coronavirus Zimbabwe |
| url | https://pubmed.ncbi.nlm.nih.gov/34882825/ http://hdl.handle.net/11408/4664 |
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