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Evaluation of a Multiplex Strip PCR Test for Infectious Uveitis: A Prospective Multicenter Study
Satoko Nakano1, Yasuhiro Tomaru2, Toshiaki Kubota1
1Department of Ophthalmology, Oita University, Yufu, Japan.
American Journal of Ophthalmology
|December 1, 2019
Summary
A new Strip Polymerase Chain Reaction (PCR) test offers a faster, cheaper, and more accurate method for diagnosing infectious uveitis compared to traditional quantitative real-time PCR (qPCR). This novel test demonstrates high sensitivity and specificity, making it ideal for clinical use.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Infectious uveitis diagnosis relies on accurate pathogen identification.
- Conventional methods like quantitative real-time PCR (qPCR) can be time-consuming and costly.
- A need exists for rapid, stable, and cost-effective diagnostic tools for ocular infections.
Purpose of the Study:
- To establish and evaluate a novel multiplex polymerase chain reaction (PCR) test, termed Strip PCR, for the detection of 24 common ocular infectious disease pathogens.
- To optimize and assess the performance of Strip PCR for diagnosing infectious uveitis using intraocular samples.
Main Methods:
- A multiplex PCR assay (Strip PCR) was developed targeting 24 common ocular pathogens.
- Intraocular samples (aqueous humor and vitreous fluid) from 722 patients across 14 institutions were analyzed.
- Strip PCR performance was evaluated against conventional quantitative real-time PCR (qPCR) and clinical diagnoses.
Main Results:
- Strip PCR demonstrated low intra- and inter-institutional variability.
- The test was optimized for 9 major pathogens and showed high accuracy in detecting pathogen DNA.
- Strip PCR exhibited superior sensitivity (98.8%) and specificity (98.5%) compared to qPCR, with strong correlation (r=0.838) to qPCR results and clinical diagnoses.
Conclusions:
- Strip PCR is an easy-to-use and reliable method for the rapid diagnosis of infectious uveitis.
- The diagnostic performance of Strip PCR is equivalent to conventional qPCR.
- Strip PCR offers a stable, prompt, accurate, and cost-effective alternative for diagnosing ocular infectious diseases.
