de Saint Vincent Benoît, Martinot Pierre, Pascal Adrien, Senneville Eric, Loiez Caroline, Pasquier Gilles, Girard Julien, Putman Sophie, Migaud Henri
Centre de Référence pour le Traitement des Infections Ostéo-Articulaires Complexes (CRIOAC), avenue du Professeur-Émile-Laine, 59037 Lille, France; University Lille, CHU Lille, ULR 4490, Département Universitaire de Chirurgie Orthopédique et Traumatologique, 59000 Lille, France; Service d'Orthopédie, Hôpital Salengro, CHU Lille, place de Verdun, 59000 Lille, France.
Centre de Référence pour le Traitement des Infections Ostéo-Articulaires Complexes (CRIOAC), avenue du Professeur-Émile-Laine, 59037 Lille, France; University Lille, CHU Lille, ULR 4490, Département Universitaire de Chirurgie Orthopédique et Traumatologique, 59000 Lille, France; Service d'Orthopédie, Hôpital Salengro, CHU Lille, place de Verdun, 59000 Lille, France.
Orthop Traumatol Surg Res. 2021 Jun;107(4):102912. doi: 10.1016/j.otsr.2021.102912. Epub 2021 Mar 31.
Diagnosis of periprosthetic infection (PPI) is crucial for management of bone and joint infection. The preoperative gold-standard is joint aspiration, providing results after 2-14 days' culture, with non-negligible false negative rates due to the fragility of certain micro-organisms and/or prior antibiotic treatment. The Synovasure™ alpha-defensin lateral flow test (Zimmer, Warsaw, IN, USA) contributes within minutes to joint fluid diagnosis of almost all infectious agents, including in case of concomitant antibiotic therapy. Validity remains controversial, notably in complex microbiological situations: multi-operated patients, diagnostic doubt despite iterative sterile culture, long-course antibiotic therapy. We extended a prospective study reported in 2018, to determine whether the test maintained diagnostic value in a larger population, assessing 1) negative (NPV) and positive (PPV) predictive value, and 2) sensitivity and specificity.
Synovasure™ maintains NPV above 95% in a broader population of microbiologically complex suspected PPI.
Synovasure™'s performance was assessed between October 2015 and October 2019 in 106 patients (112 tests) in complex diagnostic situations: 37 discordant cultures (discordant findings between 2 samples), 65 cases with clinically or biologically suspected infection but iterative sterile culture, 10 emergencies (requiring surgery, precluding antibiotic window, or mechanical failure in suspected infection), including 5 with ongoing antibiotic therapy for infection in another organ. Six tests were repeated in the same patient and same joint at >6 months' interval for strong clinical suspicion of infection. The main endpoint was the MSIS score (MusculoSkeletal Infection Society, 2018).
NPV was 98.8%, PPV 72.4%, sensitivity 95.5% and specificity 91%. Prevalence of infection was 19.6%. Only 1 of the 22 infected patients had negative Synovasure™ tests, compared to 81 of the 84 non-infected patients.
Synovasure™ is a reliable novel diagnostic test, contributing mainly to ruling out infection thanks to its strong NPV. The cost imposes sparing use, but medico-economic assessment would be worthwhile.
III; prospective of diagnostic performance.
人工关节周围感染（PPI）的诊断对于骨与关节感染的管理至关重要。术前的金标准是关节穿刺抽吸，培养2 - 14天后得出结果，但由于某些微生物的脆弱性和/或先前的抗生素治疗，假阴性率不可忽视。Synovasure™α - 防御素侧向流动检测（美国印第安纳州华沙市的 Zimmer公司生产）能在几分钟内辅助诊断关节液中几乎所有的感染病原体，包括在同时进行抗生素治疗的情况下。其有效性仍存在争议，尤其是在复杂的微生物学情况中：多次接受手术的患者、尽管反复进行无菌培养仍存在诊断疑问、长期抗生素治疗。我们扩展了一项2018年报道的前瞻性研究，以确定该检测在更大规模人群中是否保持诊断价值，评估1）阴性预测值（NPV）和阳性预测值（PPV），以及2）敏感性和特异性。
在微生物学情况复杂的疑似PPI更大规模人群中，Synovasure™的NPV保持在95%以上。
2015年10月至2019年10月期间，对106例患者（112次检测）在复杂诊断情况下评估了Synovasure™的性能：37例培养结果不一致（两个样本的检测结果不一致）、65例临床上或生物学上疑似感染但反复进行无菌培养的病例、10例急诊情况（需要手术、排除抗生素使用窗口期或疑似感染时出现机械故障），其中5例在另一个器官正在接受感染的抗生素治疗。对于强烈临床怀疑感染的患者，在同一患者的同一关节间隔>6个月重复进行了6次检测。主要终点是MSIS评分（肌肉骨骼感染学会，2018年）。
NPV为98.8%，PPV为72.4%，敏感性为95.5%，特异性为91%。感染患病率为19.6%。22例感染患者中只有1例Synovasure™检测为阴性，而84例未感染患者中有81例检测为阴性。
Synovasure™是一种可靠的新型诊断检测方法，由于其较高的NPV，主要有助于排除感染。成本较高，需谨慎使用，但进行医学经济学评估是值得的。
III级；诊断性能的前瞻性研究。
