Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex
This study investigated the diagnostic efficiencies of two assays for the detection of <i>Mycobacterium tuberculosis</i> complex: (1) the reciprocal-flow real-time polymerase chain reaction (PCR)-based GeneSoC assay and (2) the real-time PCR based GENECUBE MTB assay with quenching probe....
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| Format: | Article |
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MDPI AG
2025-01-01
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| Series: | Microorganisms |
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| Online Access: | https://www.mdpi.com/2076-2607/13/1/201 |
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| author | Kosuke Kosai Keisuke Matsumoto Takahisa Ishikawa Yasuhide Kawamoto Norihiko Akamatsu Kenji Ota Fujiko Mitsumoto-Kaseida Norihito Kaku Hiroo Hasegawa Koichi Izumikawa Hiroshi Mukae Katsunori Yanagihara |
| author_facet | Kosuke Kosai Keisuke Matsumoto Takahisa Ishikawa Yasuhide Kawamoto Norihiko Akamatsu Kenji Ota Fujiko Mitsumoto-Kaseida Norihito Kaku Hiroo Hasegawa Koichi Izumikawa Hiroshi Mukae Katsunori Yanagihara |
| author_sort | Kosuke Kosai |
| collection | DOAJ |
| description | This study investigated the diagnostic efficiencies of two assays for the detection of <i>Mycobacterium tuberculosis</i> complex: (1) the reciprocal-flow real-time polymerase chain reaction (PCR)-based GeneSoC assay and (2) the real-time PCR based GENECUBE MTB assay with quenching probe. These assays were performed for stored clinical samples and results were compared with the confirmed results based on culture and COBAS TaqMan MTB assay. A total of 53 samples (20 confirmed positives and 33 confirmed negatives) were included in the performance analysis. The GeneSoC assay showed concordance in all 53 samples, regardless of specimen type, while the GENECUBE MTB assay showed concordance in 19 of the 20 confirmed positive samples and all 33 confirmed negative samples. The overall agreement was 100.0% for the GeneSoC assay and 98.1% for the GENECUBE MTB assay. Positive and negative percent agreements were 100.0% each for the GeneSoC assay and 95.0% and 100.0%, respectively, for the GENECUBE MTB assay. Both the GeneSoC and GENECUBE MTB assays exhibited excellent performance in detecting <i>M. tuberculosis</i> complex. The GeneSoC assay is useful for independent assays of individual samples, whereas the GENECUBE MTB assay is suitable for batch assays of multiple samples. |
| format | Article |
| id | doaj-art-c237a653e6104f7e94564f2c879568a2 |
| institution | Kabale University |
| issn | 2076-2607 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Microorganisms |
| spelling | doaj-art-c237a653e6104f7e94564f2c879568a22025-01-24T13:43:02ZengMDPI AGMicroorganisms2076-26072025-01-0113120110.3390/microorganisms13010201Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> ComplexKosuke Kosai0Keisuke Matsumoto1Takahisa Ishikawa2Yasuhide Kawamoto3Norihiko Akamatsu4Kenji Ota5Fujiko Mitsumoto-Kaseida6Norihito Kaku7Hiroo Hasegawa8Koichi Izumikawa9Hiroshi Mukae10Katsunori Yanagihara11Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Hospital, Nagasaki 852-8501, JapanDepartment of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, JapanDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, JapanDepartment of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, JapanThis study investigated the diagnostic efficiencies of two assays for the detection of <i>Mycobacterium tuberculosis</i> complex: (1) the reciprocal-flow real-time polymerase chain reaction (PCR)-based GeneSoC assay and (2) the real-time PCR based GENECUBE MTB assay with quenching probe. These assays were performed for stored clinical samples and results were compared with the confirmed results based on culture and COBAS TaqMan MTB assay. A total of 53 samples (20 confirmed positives and 33 confirmed negatives) were included in the performance analysis. The GeneSoC assay showed concordance in all 53 samples, regardless of specimen type, while the GENECUBE MTB assay showed concordance in 19 of the 20 confirmed positive samples and all 33 confirmed negative samples. The overall agreement was 100.0% for the GeneSoC assay and 98.1% for the GENECUBE MTB assay. Positive and negative percent agreements were 100.0% each for the GeneSoC assay and 95.0% and 100.0%, respectively, for the GENECUBE MTB assay. Both the GeneSoC and GENECUBE MTB assays exhibited excellent performance in detecting <i>M. tuberculosis</i> complex. The GeneSoC assay is useful for independent assays of individual samples, whereas the GENECUBE MTB assay is suitable for batch assays of multiple samples.https://www.mdpi.com/2076-2607/13/1/201molecular diagnosisrapid detectionreciprocal-flow PCRquenching probe |
| spellingShingle | Kosuke Kosai Keisuke Matsumoto Takahisa Ishikawa Yasuhide Kawamoto Norihiko Akamatsu Kenji Ota Fujiko Mitsumoto-Kaseida Norihito Kaku Hiroo Hasegawa Koichi Izumikawa Hiroshi Mukae Katsunori Yanagihara Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex Microorganisms molecular diagnosis rapid detection reciprocal-flow PCR quenching probe |
| title | Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex |
| title_full | Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex |
| title_fullStr | Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex |
| title_full_unstemmed | Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex |
| title_short | Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of <i>Mycobacterium tuberculosis</i> Complex |
| title_sort | clinical evaluation of a rapid reciprocal flow pcr assay and real time pcr assay with quenching probe for detection of i mycobacterium tuberculosis i complex |
| topic | molecular diagnosis rapid detection reciprocal-flow PCR quenching probe |
| url | https://www.mdpi.com/2076-2607/13/1/201 |
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