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Clinical performance of the multiplex solid-phase "Direct Strip PCR" for infectious uveitis: a multicenter diagnostic
Satoko Nakano1, Sunao Sugita2,3, Hiroshi Takase4
1Department of Ophthalmology, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-cho, Yufu, Oita, 879-5593, Japan. sanakano@oita-u.ac.jp.
Japanese Journal of Ophthalmology
|April 2, 2026
Summary
Direct Strip PCR accurately diagnoses infectious uveitis by detecting major pathogens. This multiplex real-time PCR kit shows high agreement with quantitative PCR, supporting its clinical use.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Infectious uveitis diagnosis relies on identifying causative pathogens.
- Multiplex PCR offers a potential solution for simultaneous detection of multiple infectious agents.
- Standard PCR methods often require DNA extraction, adding complexity and time.
Purpose of the Study:
- To assess the clinical performance of the Direct Strip PCR kit for diagnosing infectious uveitis.
- To compare the diagnostic accuracy of Direct Strip PCR against quantitative PCR (qPCR).
Main Methods:
- A multicenter, prospective diagnostic accuracy study was conducted.
- 475 ocular fluid samples (aqueous humor and vitreous fluid) were analyzed.
- Direct Strip PCR was compared with qPCR for concordance and DNA copy-number correlation.
Main Results:
- Direct Strip PCR demonstrated high concordance with qPCR in both aqueous humor and vitreous fluid.
- Percent positive agreement (PPA) ranged from 95.7% to 98.0%, and percent negative agreement (PNA) from 97.1% to 99.2%.
- Strong correlation in DNA copy numbers (r = 0.948-0.996) was observed between the two methods.
Conclusions:
- Direct Strip PCR is a reliable method for detecting major pathogens in infectious uveitis.
- The kit's extraction-free, solid-phase format offers practical advantages for clinical application and regulatory approval.
- High concordance and quantitative results support its use in disease monitoring and global dissemination.
