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Updated: Sep 20, 2026

A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
[Special comments--problems in systematic review for diagnostic accuracy of high-sensitivity C-reactive protein assay
1Department of Laboratory Medicine, National Defense Medical College, Tokorozawa, 359-8513.
Abstract:
We conducted a systematic review for the diagnostic accuracy of high-sensitivity C-reactive protein assay for neonatal infection. In total, 558 relevant published reports were found in a search of MEDLINE and Igaku-Chuo-Shi. With our inclusion and exclusion criteria, we finally selected 30 primary studies for meta-analysis. We critically appraised the quality of selected clinical studies and then extracted sensitivity and specificity data from each article for meta-analysis. There was only one article that fulfilled our three major standards for quality assessment(rank A; high-quality), while 19 studies which fulfilled only one criterion were assigned to rank C(low-quality). Most studies neither took careful consideration of the blindness against the results of the index test nor described this methodological standard. Lack of qualified primary studies may have had substantial influence on the summary estimates. Insufficient number of primary studies for meta-analysis and their unsatisfactory quality would be improved by the addition of supplemental results retrieved from raw data, which the authors of clinical studies did not present in their articles.
Insights
High-sensitivity C-reactive protein assays show variable diagnostic accuracy for neonatal infection. The quality of primary studies included in meta-analyses was often low, potentially impacting reliability.
Area of Science:
- Clinical Medicine
- Biochemistry
Background:
- Neonatal infections pose significant health risks.
- Accurate diagnostic tools are crucial for timely treatment.
- High-sensitivity C-reactive protein (hs-CRP) is a potential biomarker.
Purpose of the Study:
- To systematically review the diagnostic accuracy of hs-CRP assays for neonatal infection.
- To evaluate the quality of existing primary studies.
Main Methods:
- Systematic review and meta-analysis of published reports.
- Searched MEDLINE and Igaku-Chuo-Shi databases.
- Included 30 primary studies after applying selection criteria.
- Critically appraised study quality and extracted sensitivity/specificity data.
Main Results:
- Only one of 30 studies met high-quality standards (Rank A).
- Nineteen studies were classified as low-quality (Rank C).
- Most studies lacked methodological rigor, particularly regarding blinding.
- Poor study quality may have influenced meta-analysis results.
Conclusions:
- The diagnostic accuracy of hs-CRP for neonatal infection is limited by the low quality of available primary studies.
- Future research requires improved methodological standards.
- Accessing raw data from studies could enhance meta-analysis reliability.
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