Affiliations: [a] The Chinese PLA 309th Hospital, Beijing 100091, China | [b] BioChain (Beijing) Science and Technology, Inc., Beijing 100176, China | [c] Graduate School of Medicine, Hebei North University, Zhangjiakou, Hebei 075000, China
Correspondence:
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Corresponding authors: Yuemin Li, Department of Radiotherapy, The Chinese PLA 309th Hospital,
No. 17, Heishanhu Road, Haidian District, Beijing 100091, China. Tel.: +86 10 66775222; E-mail:
[email protected]. Lele Song, Department of Radiotherapy, The Chinese PLA 309th
Hospital, No. 17, Heishanhu Road, Haidian District, Beijing 100091, China. Tel.: +86 13240149188; E-mail: [email protected]
Abstract: BACKGROUND: The applications of the SEPT9 assay are expanding from CRC early
diagnosis to screening, therapeutic effect monitoring and prognosis
prediction. Its performance in these areas has not been thoroughly examined. OBJECTIVE: We aim to evaluate the performance of the SEPT9 assay in CRC
screening, diagnosis and therapy by reviewing the current data published in
these aspects. METHODS: The Ovid MEDLINE, EMBASE, CBMdisc (China Biology Medicine disc) and
CJFD (Chinese Journal Full - text Database) database were searched for
potential reports on the assay performance. Letters, reviews, meta-analysis
and guidelines, basic research studies and articles irrelevant to mSEPT9
detection assays were excluded. Finally, data from 19 studies was summarized
and systematically reviewed to clarify the assay performance. RESULTS: 2/3 algorithm provided the best overall performance in diagnosis
and screening, while the 1/3 algorithm exhibited the best sensitivity in
screening. The combination of SEPT9 assay with FIT and/or CEA enhanced the
CRC detection rate in screening. The SEPT9 assay appeared to be effective in
monitoring the therapeutic effect and may potentially predict the CRC
recurrence and survival. CONCLUSION: The SEPT9 assay exhibited satisfactory performance in CRC
diagnosis and screening, while more evidence is needed for therapeutic
effect monitoring and prognosis prediction.
