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Rapid detection of periprosthetic joint infection using a combination of 16s rDNA polymerase chain reaction and
V Janz1, J Schoon2, C Morgenstern3
1Center for Musculoskeletal Surgery, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany viktor.janz@charite.de.
Objectives:
The objective of this study was to develop a test for the rapid (within 25 minutes) intraoperative detection of bacteria from synovial fluid to diagnose periprosthetic joint infection (PJI).
Methods:
The 16s rDNA test combines a polymerase chain reaction (PCR) for amplification of 16s rDNA with a lateral flow immunoassay in one fully automated system. The synovial fluid of 77 patients undergoing joint aspiration or primary or revision total hip or knee surgery was prospectively collected. The cohort was divided into a proof-of-principle cohort (n = 17) and a validation cohort (n = 60). Using the proof-of-principle cohort, an optimal cut-off for the discrimination between PJI and non-PJI samples was determined. PJI was defined as detection of the same bacterial species in a minimum of two microbiological samples, positive histology, and presence of a sinus tract or intra-articular pus.
Results:
The 16s rDNA test proved to be very robust and was able to provide a result in 97% of all samples within 25 minutes. The 16s rDNA test was able to diagnose PJI with a sensitivity of 87.5% and 82%, and a specificity of 100% and 89%, in the proof-of-principle and validation cohorts, respectively. The microbiological culture of synovial fluid achieved a sensitivity of 80% and a specificity of 93% in the validation cohort.
Conclusion:
The 16s rDNA test offers reliable intraoperative detection of all bacterial species within 25 minutes with a sensitivity and specificity comparable with those of conventional microbiological culture of synovial fluid for the detection of PJI. The 16s rDNA test performance is independent of possible blood contamination, culture time and bacterial species.Cite this article: V. Janz, J. Schoon, C. Morgenstern, B. Preininger, S. Reinke, G. Duda, A. Breitbach, C. F. Perka, S. Geissler. Rapid detection of periprosthetic joint infection using a combination of 16s rDNA polymerase chain reaction and lateral flow immunoassay: A Pilot Study. Bone Joint Res 2018;7:12-19. DOI: 10.1302/2046-3758.71.BJR-2017-0103.R2.
Insights
A new 16s rDNA test rapidly detects bacteria in synovial fluid within 25 minutes, aiding in the diagnosis of periprosthetic joint infection (PJI). This molecular test offers high accuracy, comparable to traditional methods, for timely intraoperative results.
Area of Science:
- Orthopedics
- Microbiology
- Molecular Diagnostics
Background:
- Periprosthetic joint infection (PJI) is a severe complication of joint replacement surgery.
- Accurate and rapid diagnosis of PJI is crucial for effective treatment and patient outcomes.
- Current diagnostic methods, such as microbiological culture, can be time-consuming.
Purpose of the Study:
- To develop and validate a rapid (within 25 minutes) intraoperative test for bacterial detection in synovial fluid.
- To diagnose periprosthetic joint infection (PJI) effectively.
- To assess the performance of a novel 16s rDNA test compared to conventional methods.
Main Methods:
- A novel 16s rDNA test was developed, combining polymerase chain reaction (PCR) with lateral flow immunoassay in an automated system.
- Synovial fluid samples from 77 patients undergoing hip or knee surgery were prospectively collected.
- The test was validated in two cohorts (n=17 and n=60), with PJI defined by established microbiological and clinical criteria.
Main Results:
- The 16s rDNA test provided results for 97% of samples within 25 minutes.
- The test demonstrated high diagnostic accuracy for PJI: sensitivity of 87.5% and specificity of 100% in the proof-of-principle cohort, and 82% sensitivity and 89% specificity in the validation cohort.
- Performance was robust, independent of blood contamination, culture time, or bacterial species.
Conclusions:
- The 16s rDNA test enables reliable intraoperative detection of bacterial species for PJI diagnosis within 25 minutes.
- Its sensitivity and specificity are comparable to conventional synovial fluid culture.
- This rapid test offers a significant advancement for intraoperative decision-making in PJI management.
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