Diagnostic accuracy of the alpha defensin lateral flow device (Synovasure) for periprosthetic infections in microbiologically complex situations: A study of 42 cases in a French referral centre

Vincent, Benoit; Migaud, Henri; Senneville, É.; Loïez, Caroline; Pasquier, Gilles; Girard, Julien; Putman, Sophie

doi:10.1016/j.otsr.2018.01.018

Cited by 30 publications

(15 citation statements)

References 22 publications

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“…The technique most commonly used today for determination of AD from synovial fluid in PJI is commercially available under the name Synovasure ® PJI test. This qualitative test is based on the method of immunochromatographic lateral flow [11,12,19]. The first studies of this method were highly optimistic, with the results of those examinations showed specificity and sensitivity exceeding 90% [11,12].…”

Section: Discussionmentioning

confidence: 99%

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High-Performance Liquid Chromatography as a Novel Method for the Determination of α-Defensins in Synovial Fluid for Diagnosis of Orthopedic Infections

et al. 2020

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The α-defensins (AD) present in synovial fluid have been regarded as constituting the most accurate periprosthetic joint infection (PJI) biomarker. The methods most commonly used for estimating AD as a biomarker are the qualitative Synovasure® PJI tests, based on the technique of lateral flow, and quantitative enzyme-linked immunosorbent assay (ELISA). Here, we propose a novel test based on detecting α-defensins in synovial fluid by high-performance liquid chromatography (HPLC). Synovial fluid was collected from 157 patients diagnosed with PJI, infectious arthritis (IA), arthrosis, reactive arthritis, and rheumatoid arthritis. AD concentrations in the fluid were determined by HPLC, and these same samples were used for additional diagnostic analyses. The results were statistically processed to calculate cutoff concentrations for PJI and IA. HPLC testing showed a sensitivity of 94% and a specificity of 92% for diagnosis of PJI, and a sensitivity of 97% and a specificity of 87% for diagnosis of IA. Using HPLC, we detected in synovial fluid a combination of three α-defensins: human neutrophil peptides HNP1, HNP2, and HNP3. All measured AD concentration values shown in this work refer to the sum of these three individual concentrations. Our study shows that the HPLC method meets the conditions for measuring precise concentrations of the sum of AD and can be recommended as part of a diagnostic array for PJI and IA diagnostics. By this method, we have verified that higher levels of AD in synovial fluid can also be seen in rheumatoid illnesses, crystal arthropathies, and reactive arthritis.

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Section: Discussionmentioning

confidence: 99%

“…The false positive results obtained by determining AD level in PJI diagnosis may occur in patients with crystal arthropathies [22], as well as in cases of rheumatoid arthritis and reactive arthritis [3,23]. Another possible cause of elevated AD levels in joint fluid can be a presence of metallosis around the joint replacement [13,19].…”

Section: Discussionmentioning

confidence: 99%

High-Performance Liquid Chromatography as a Novel Method for the Determination of α-Defensins in Synovial Fluid for Diagnosis of Orthopedic Infections

et al. 2020

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“…However, only up to six studies on the lateral flow test were included. After these studies, the diagnostic accuracy of α-defensin for PJI has been widely assessed with inconsistent results [22, 24, 26, 39–43]. Therefore, the purpose of the current meta-analysis was to reassess the diagnostic value of laboratory-based immunoassay and the lateral flow test for the detection of synovial fluid α-defensin against PJI.…”

Section: Introductionmentioning

confidence: 99%

Synovial fluid α-defensin in the diagnosis of periprosthetic joint infection: the lateral flow test is an effective intraoperative detection method

et al. 2019

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Background Synovial fluid α-defensin is a valuable biomarker for periprosthetic joint infection (PJI). Its diagnostic value for PJI has been widely evaluated recently, but results are inconsistent, especially for different test methods. The objective of this study was to evaluate the diagnostic value of laboratory-based immunoassay and lateral flow testing for the detection of α-defensin against hip and knee PJI. Methods We systematically searched MEDLINE and EMBASE for articles on the diagnostic accuracy of α-defensin for PJI published up to September 2018. The pooled sensitivity, specificity, area under the curve (AUC), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were calculated for the evaluation of the diagnostic value of α-defensin for PJI. Results Nineteen studies were included. Eleven evaluated laboratory-based immunoassay, and 10 evaluated the lateral flow test results. The pooled sensitivity, specificity, AUC, PLR, NLR, and DOR of laboratory-based immunoassays were 0.96 (95% confidence interval [CI] 0.90–0.98), 0.97 (95% CI 0.95–0.99), 0.99 (95% CI 0.98–1.00), 35.0 (95% CI 18.5–66.2), 0.04 (95% CI 0.02–0.11), and 811 (95% CI 220–2990), respectively. The pooled sensitivity, specificity, AUC, PLR, NLR, and DOR of the lateral flow test were 0.86 (95% CI 0.81–0.91), 0.96 (95% CI 0.93–0.98), 0.95 (95% CI 0.93–0.97), 21.2 (95% CI 11.7–38.5), 0.14 (95% CI 0.10–0.21), and 148 (95% CI 64–343), respectively. Conclusions Laboratory-based immunoassay of α-defensin is highly accurate for the diagnosis of hip and knee PJI. The lateral flow test is less sensitive but still a useful intraoperative detection tool for PJI.

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“…Twenty-three studies [ 12 , 16 , 21 , 22 , 25 , 27 – 39 , 41 – 44 , 47 ] were prospective, and twelve studies [ 14 , 15 , 23 , 24 , 26 , 40 , 45 , 46 , 48 – 51 ] were retrospective. Thirty-four studies [ 12 , 15 , 16 , 21 – 51 ] were cohort studies whereas only one study [ 14 ] was a case-control study.…”

Section: Resultsmentioning

confidence: 99%

“…Thirty-four studies [ 12 , 15 , 16 , 21 – 51 ] were cohort studies whereas only one study [ 14 ] was a case-control study. Twenty-one studies involving a total of 1928 patients (650 joints with PJI) explored the diagnostic accuracy of alpha-defensin [ 12 , 14 , 15 , 23 – 27 , 29 , 30 , 33 – 35 , 37 , 38 , 41 , 45 , 46 , 48 – 50 ], among which eight studies [ 12 , 27 , 29 , 30 , 34 , 35 , 37 , 48 ] used a lateral flow test to assess alpha-defensin, twelve [ 14 , 15 , 24 – 26 , 33 , 38 , 41 , 45 , 46 , 49 , 50 ] adopted a laboratory-based alpha-defensin immunoassay, and the testing methods used were not reported in one studies [ 23 ]. The mean ages of included patients ranged from 61.7 to 71.0 years, and the proportion of males ranged from 40.3% to 61.5%.…”

Section: Resultsmentioning

confidence: 99%

Alpha-Defensin versus Leukocyte Esterase in Periprosthetic Joint Infection: An Updated Meta-Analysis

Shi

Gao

et al. 2020

BioMed Research International

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Periprosthetic joint infection (PJI) is a devastating complication after arthroplasty. Prompt establishment of an infection diagnosis is critical but can be very challenging at present. In order to evaluate the diagnostic accuracy of alpha-defensin or leukocyte esterase for PJI, we performed systematic research in PubMed, Embase, and Cochrane Library to retrieve relevant studies. Data extraction and quality assessment were performed by two reviewers independently. A total of thirty-one eligible studies were finally included in the quantitative analysis. The pooled sensitivity and specificity of alpha-defensin (21 studies) for the diagnosis of PJI were 0.89 (95% confidence interval (CI), 0.83 to 0.93) and 0.96 (95% CI, 0.95 to 0.97), respectively. The value of the pooled diagnostic odds ratios (DOR) of alpha-defensin for PJI was 209.14 (95% CI, 97.31 to 449.50), and the area under the curve (AUC) was 0.98 (95% CI, 0.96 to 0.99). The pooled sensitivity and specificity of leukocyte esterase (17 studies) for the diagnosis of PJI were 0.90 (95% CI, 0.84 to 0.95) and 0.96 (95% CI, 0.93 to 0.97), respectively. The value of the DOR of leukocyte esterase for PJI was 203.23 (95% CI, 96.14 to 429.61), and the AUC was 0.98 (95% CI, 0.96 to 0.99). Based on the results of our meta-analysis, we can conclude that alpha-defensin and leukocyte esterase are valuable synovial fluid markers for identifying PJI with comparable high diagnostic accuracy.

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Diagnostic accuracy of the alpha defensin lateral flow device (Synovasure) for periprosthetic infections in microbiologically complex situations: A study of 42 cases in a French referral centre

Abstract: III, prospective study of diagnostic accuracy.

Cited by 30 publications

References 22 publications

High-Performance Liquid Chromatography as a Novel Method for the Determination of α-Defensins in Synovial Fluid for Diagnosis of Orthopedic Infections

High-Performance Liquid Chromatography as a Novel Method for the Determination of α-Defensins in Synovial Fluid for Diagnosis of Orthopedic Infections

Synovial fluid α-defensin in the diagnosis of periprosthetic joint infection: the lateral flow test is an effective intraoperative detection method

Alpha-Defensin versus Leukocyte Esterase in Periprosthetic Joint Infection: An Updated Meta-Analysis

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