Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood
Background: Fecal occult blood tests have been widely used to screen for colorectal cancer. SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal occult blood test with an immunochemical method that utilizes FOB Gold reagents. We evaluated the performance of SENTiFIT 270 using the FOB Gold reagent....
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Korean Society of Clinical Microbiology
2019-06-01
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| Series: | Annals of Clinical Microbiology |
| Subjects: | |
| Online Access: | https://www.acm.or.kr/article_aws/?num=KJCM2019_29 |
| _version_ | 1818280188472983552 |
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| author | Da Young Kang Dokyun Kim Keonhan Kim In-Ho Jang Seok Hoon Jeong |
| author_facet | Da Young Kang Dokyun Kim Keonhan Kim In-Ho Jang Seok Hoon Jeong |
| author_sort | Da Young Kang |
| collection | DOAJ |
| description | Background: Fecal occult blood tests have been
widely used to screen for colorectal cancer.
SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal
occult blood test with an immunochemical method
that utilizes FOB Gold reagents. We evaluated the
performance of SENTiFIT 270 using the FOB Gold
reagent. In addition, FOB Gold was evaluated with
the HITACHI 7180 (Hitachi Ltd., Japan).Methods: The precision and linearity of the SENTiFIT
270 was evaluated in accordance with applicable
Clinical and Laboratory Standard Institute guidelines.
The comparison study between SENTiFIT 270-FOB
Gold and the OC-Sensor (Eiken chemical Co.,
Japan) was performed using stool specimens.Results: In the precision evaluation, the total precision
of SENTiFIT 270-FOB Gold was 4.94% and
2.54% at high and low concentrations, respectively.
The HITACHI 7180-FOB Gold had excellent precision
of 4.60% and 2.09% at high and low concentrations,
respectively. Linearity was also excellent for the
SENTiFIT 270-FOB Gold and HITACHI 7180-FOB
Gold at 0.9987 and 0.9986, respectively. The SENTITIF
270-FOB Gold showed excellent agreement with a
kappa value of 0.830 and a concordance rate of
93.6%. The HITACHI 7180-FOB Gold showed high
agreement with a kappa value of 0.832 and a concordance
rate of 93.9%.Conclusion: The SENTiFIT 270-FOB Gold showed
excellent performance in accuracy, linearity, and comparative
inspection ability. (Ann Clin Microbiol 2019;22:29-34) |
| first_indexed | 2024-12-12T23:45:15Z |
| format | Article |
| id | doaj.art-915f4e936cd5414a9fcb75671cf554fc |
| institution | Directory Open Access Journal |
| issn | 2288-0585 2288-6850 |
| language | English |
| last_indexed | 2024-12-12T23:45:15Z |
| publishDate | 2019-06-01 |
| publisher | Korean Society of Clinical Microbiology |
| record_format | Article |
| series | Annals of Clinical Microbiology |
| spelling | doaj.art-915f4e936cd5414a9fcb75671cf554fc2022-12-22T00:06:52ZengKorean Society of Clinical MicrobiologyAnnals of Clinical Microbiology2288-05852288-68502019-06-01222293410.5145/ACM.2019.22.2.29KJCM2019_29Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult BloodDa Young Kang0Dokyun Kim1Keonhan Kim2In-Ho Jang3Seok Hoon Jeong4 Department of Laboratory Medicine and Research Institute of Bacterial Resistance,Yonsei University College of Medicine, Seoul, Department of Laboratory Medicine and Research Institute of Bacterial Resistance,Yonsei University College of Medicine, Seoul, Department of Laboratory Medicine and Research Institute of Bacterial Resistance,Yonsei University College of Medicine, Seoul, Department of Clinical Pathology, Sangji University College of Health Science, Wonju Department of Laboratory Medicine and Research Institute of Bacterial Resistance,Yonsei University College of Medicine, Seoul, Background: Fecal occult blood tests have been widely used to screen for colorectal cancer. SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal occult blood test with an immunochemical method that utilizes FOB Gold reagents. We evaluated the performance of SENTiFIT 270 using the FOB Gold reagent. In addition, FOB Gold was evaluated with the HITACHI 7180 (Hitachi Ltd., Japan).Methods: The precision and linearity of the SENTiFIT 270 was evaluated in accordance with applicable Clinical and Laboratory Standard Institute guidelines. The comparison study between SENTiFIT 270-FOB Gold and the OC-Sensor (Eiken chemical Co., Japan) was performed using stool specimens.Results: In the precision evaluation, the total precision of SENTiFIT 270-FOB Gold was 4.94% and 2.54% at high and low concentrations, respectively. The HITACHI 7180-FOB Gold had excellent precision of 4.60% and 2.09% at high and low concentrations, respectively. Linearity was also excellent for the SENTiFIT 270-FOB Gold and HITACHI 7180-FOB Gold at 0.9987 and 0.9986, respectively. The SENTITIF 270-FOB Gold showed excellent agreement with a kappa value of 0.830 and a concordance rate of 93.6%. The HITACHI 7180-FOB Gold showed high agreement with a kappa value of 0.832 and a concordance rate of 93.9%.Conclusion: The SENTiFIT 270-FOB Gold showed excellent performance in accuracy, linearity, and comparative inspection ability. (Ann Clin Microbiol 2019;22:29-34)https://www.acm.or.kr/article_aws/?num=KJCM2019_29colon cancerlinearityoccult bloodprecisionsentifit 270-fob gold |
| spellingShingle | Da Young Kang Dokyun Kim Keonhan Kim In-Ho Jang Seok Hoon Jeong Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood Annals of Clinical Microbiology colon cancer linearity occult blood precision sentifit 270-fob gold |
| title | Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood |
| title_full | Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood |
| title_fullStr | Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood |
| title_full_unstemmed | Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood |
| title_short | Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood |
| title_sort | performance evaluation of sentifit 270 and fob gold reagent for detecting fecal occult blood |
| topic | colon cancer linearity occult blood precision sentifit 270-fob gold |
| url | https://www.acm.or.kr/article_aws/?num=KJCM2019_29 |
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