STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays
The demand for assays that can rapidly and accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains high. We evaluated the performance of two rapid real-time reverse transcription polymerase chain reaction (RT-qPCR) assays (STANDARD M10 SARS-CoV-2 and Xpert Xpress SARS-...
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MDPI AG
2022-08-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/12/8/1998 |
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| author | Seri Jeong Nuri Lee Su Kyung Lee Eun-Jung Cho Jungwon Hyun Min-Jeong Park Wonkeun Song Hyun Soo Kim |
| author_facet | Seri Jeong Nuri Lee Su Kyung Lee Eun-Jung Cho Jungwon Hyun Min-Jeong Park Wonkeun Song Hyun Soo Kim |
| author_sort | Seri Jeong |
| collection | DOAJ |
| description | The demand for assays that can rapidly and accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains high. We evaluated the performance of two rapid real-time reverse transcription polymerase chain reaction (RT-qPCR) assays (STANDARD M10 SARS-CoV-2 and Xpert Xpress SARS-CoV-2) against conventional RT-qPCR assays (STANDARD M nCoV and Allplex SARS-CoV-2) for detecting SARS-CoV-2. A total of 225 swab samples were collected and tested using the four assays. The STANDARD M10 SARS-CoV-2 assay showed 97.4% positive percent agreement (PPA) and 100.0% negative percent agreement (NPA) compared to the STANDARD M nCoV assay and Allplex SARS-CoV-2 assay. STANDARD M10 exhibited high performance except in samples with low viral loads (cycle threshold (Ct) > 30). Xpert Xpress showed PPA and NPA of 100.0% compared to the two conventional RT-qPCR assays. The kappa coefficient (Κ) showed nearly almost perfect agreement between each assay and conventional RT-qPCR assays. The correlations of Ct values between the two rapid RT-qPCR and conventional RT-qPCR assays were >0.8, indicating strong correlations. All included assays could detect SARS-CoV-2 variants, such as the Alpha, Beta, and Gamma variants. The recently developed STANDARD M10 has a shorter turnaround time and random-access detection on automated devices, thereby facilitating efficient testing in emergency settings. |
| first_indexed | 2024-03-09T13:34:12Z |
| format | Article |
| id | doaj.art-5a36262628904161bbb856ea86aac095 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-09T13:34:12Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-5a36262628904161bbb856ea86aac0952023-11-30T21:13:54ZengMDPI AGDiagnostics2075-44182022-08-01128199810.3390/diagnostics12081998STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR AssaysSeri Jeong0Nuri Lee1Su Kyung Lee2Eun-Jung Cho3Jungwon Hyun4Min-Jeong Park5Wonkeun Song6Hyun Soo Kim7Department of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, KoreaDepartment of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, KoreaDepartment of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7, Keunjaebong-gil, Hwaseong 18450, KoreaDepartment of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7, Keunjaebong-gil, Hwaseong 18450, KoreaDepartment of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7, Keunjaebong-gil, Hwaseong 18450, KoreaDepartment of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, KoreaDepartment of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, KoreaDepartment of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7, Keunjaebong-gil, Hwaseong 18450, KoreaThe demand for assays that can rapidly and accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains high. We evaluated the performance of two rapid real-time reverse transcription polymerase chain reaction (RT-qPCR) assays (STANDARD M10 SARS-CoV-2 and Xpert Xpress SARS-CoV-2) against conventional RT-qPCR assays (STANDARD M nCoV and Allplex SARS-CoV-2) for detecting SARS-CoV-2. A total of 225 swab samples were collected and tested using the four assays. The STANDARD M10 SARS-CoV-2 assay showed 97.4% positive percent agreement (PPA) and 100.0% negative percent agreement (NPA) compared to the STANDARD M nCoV assay and Allplex SARS-CoV-2 assay. STANDARD M10 exhibited high performance except in samples with low viral loads (cycle threshold (Ct) > 30). Xpert Xpress showed PPA and NPA of 100.0% compared to the two conventional RT-qPCR assays. The kappa coefficient (Κ) showed nearly almost perfect agreement between each assay and conventional RT-qPCR assays. The correlations of Ct values between the two rapid RT-qPCR and conventional RT-qPCR assays were >0.8, indicating strong correlations. All included assays could detect SARS-CoV-2 variants, such as the Alpha, Beta, and Gamma variants. The recently developed STANDARD M10 has a shorter turnaround time and random-access detection on automated devices, thereby facilitating efficient testing in emergency settings.https://www.mdpi.com/2075-4418/12/8/1998SARS-CoV-2real-time PCRcomparisonvariant |
| spellingShingle | Seri Jeong Nuri Lee Su Kyung Lee Eun-Jung Cho Jungwon Hyun Min-Jeong Park Wonkeun Song Hyun Soo Kim STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays Diagnostics SARS-CoV-2 real-time PCR comparison variant |
| title | STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays |
| title_full | STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays |
| title_fullStr | STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays |
| title_full_unstemmed | STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays |
| title_short | STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays |
| title_sort | standard m10 sars cov 2 assay for rapid detection of sars cov 2 comparison of four real time pcr assays |
| topic | SARS-CoV-2 real-time PCR comparison variant |
| url | https://www.mdpi.com/2075-4418/12/8/1998 |
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