Article type
Abstract
Objective
Blood calprotectin quantitative high-quality immunoassay is a technique for quantifying the amount of calprotectin in plasma and serum samples using high quality immunoassays, such as the immunoturbidimetric assay, for the differential diagnosis of IBD and non-IBD in patients with suspected IBD. The objective of this assessment was to determine the safety and effectiveness of the technique.
Method
A literature search was conducted using five domestic databases, including KoreaMed, and overseas databases, including Ovid-MEDLINE, Ovid-EMBASE, and the Cochrane Library. The search strategy generated a total of 1,993 articles, and after removing 459 duplicate results, 1,534 studies were reviewed against the inclusion and exclusion criteria. As a result, a total of 13 studies were selected for assessment.
Each step, from the literature search to the application of the inclusion criteria and data extraction, was performed independently by the subcommittee and two assessors. The quality of each study was assessed using the Scottish Intercollegiate Guidelines Network checklist, and the assessment results were described based on the quality appraisal results and level of evidence.
Results
A total of 13 diagnostic evaluation studies were selected for the safety and effectiveness assessments for blood calprotectin quantitative high-quality immunoassay.
Effectiveness
The effectiveness of the technique was assessed based on the diagnostic accuracy, correlation and agreement with a comparator, and association with disease. The results were analyzed by the assay used.
Given that this test is intended to replace the fecal calprotectin test, the subcommittee intended to confirm its equivalence or superiority to the comparator. However, there were only two studies conducted on patients with suspected IBD, and the reported diagnostic accuracy was low, hindering generalization of the findings.
Conclusion
Therefore, the subcommittee presented the following results based on the current literature evidence:
Blood calprotectin quantitative high-quality immunoassay is a safe technique for quantifying the amount of calprotectin in plasma and serum samples using high-quality immunoassays, such as the immunoturbidimetric assay, for the differential diagnosis of IBD and non-IBD in patients with suspected IBD; however, further research is needed to determine its effectiveness (Level of evidence D, Technology category II-a).
Blood calprotectin quantitative high-quality immunoassay is a technique for quantifying the amount of calprotectin in plasma and serum samples using high quality immunoassays, such as the immunoturbidimetric assay, for the differential diagnosis of IBD and non-IBD in patients with suspected IBD. The objective of this assessment was to determine the safety and effectiveness of the technique.
Method
A literature search was conducted using five domestic databases, including KoreaMed, and overseas databases, including Ovid-MEDLINE, Ovid-EMBASE, and the Cochrane Library. The search strategy generated a total of 1,993 articles, and after removing 459 duplicate results, 1,534 studies were reviewed against the inclusion and exclusion criteria. As a result, a total of 13 studies were selected for assessment.
Each step, from the literature search to the application of the inclusion criteria and data extraction, was performed independently by the subcommittee and two assessors. The quality of each study was assessed using the Scottish Intercollegiate Guidelines Network checklist, and the assessment results were described based on the quality appraisal results and level of evidence.
Results
A total of 13 diagnostic evaluation studies were selected for the safety and effectiveness assessments for blood calprotectin quantitative high-quality immunoassay.
Effectiveness
The effectiveness of the technique was assessed based on the diagnostic accuracy, correlation and agreement with a comparator, and association with disease. The results were analyzed by the assay used.
Given that this test is intended to replace the fecal calprotectin test, the subcommittee intended to confirm its equivalence or superiority to the comparator. However, there were only two studies conducted on patients with suspected IBD, and the reported diagnostic accuracy was low, hindering generalization of the findings.
Conclusion
Therefore, the subcommittee presented the following results based on the current literature evidence:
Blood calprotectin quantitative high-quality immunoassay is a safe technique for quantifying the amount of calprotectin in plasma and serum samples using high-quality immunoassays, such as the immunoturbidimetric assay, for the differential diagnosis of IBD and non-IBD in patients with suspected IBD; however, further research is needed to determine its effectiveness (Level of evidence D, Technology category II-a).