Abstract：
BACKGROUND: Calprotectin is a protein endowed with antimicrobial properties, rendering it a distinctive marker for infection. Two methods are currently available for the assay of calprotectin: the enzyme-linked immunosorbent assay (ELISA) and the lateral flow test (LFT). We aimed to assess the diagnostic accuracy of synovial fluid calprotectin and to compare the accuracy of the laboratory-based test and the qualitative assessment for the diagnosis of hip and knee prosthetic infection.
METHODS: We searched (from inception to November 2023) MEDLINE, Scopus, EMBASE, Web of Science, and Cochrane for studies on calprotectin in the diagnosis of periprosthetic joint infection (PJI). Sensitivity, specificity, positive and negative likelihood ratio (LR), and diagnostic odds ratio were analyzed. The receiver-operating curve for each method was calculated.
RESULTS: We included 14 articles in our meta-analysis, including 902 patients who underwent total hip and knee arthroplasties revision; 331 (37%) had a joint infection according to MSIS, MSIS-modified criteria, ICM 2018 and EBJIS 2021. Considering the false-positive result rate of 6% and false-negative result rate of 7%, pooled sensitivity and specificity were 0.92 (95% CI 0.89-0.94) and 0.93 (0.91-0.95), respectively. The area under the curve (AUC) was 0.93 (95% CI 0.91-0.94). No statistical differences in terms of sensitivity and specificity were found between ELISA and LFT. The pooled sensitivity and specificity of the two calprotectin assessment methods were: LFT 0.90 (95% CI 0.869-0.935) and 0.92 (95% CI 0.894-0.941), respectively; ELISA 0.96 (95% CI 0.914-0.986) and 0.97 (95% CI 0.934-0.988), respectively. The diagnostic odds ratio of the ELISA was superior to that of the LFT (906.6667, 95% CI 271.2686-3030.3712 versus 113.8886, 95% CI 70.4001-184.2414; p < 0.001). The AUC for ELISA and LFT was 0.968 (95% CI 0.944-0.984) and 0.915 (95% CI 0.895-0.933), respectively.
CONCLUSIONS: Detection of synovial calprotectin is an accurate test for diagnosis of hip and knee prosthetic infections. The diagnostic accuracy of the two calprotectin assessment methods is almost comparable. The LFT is a valid, rapid, and more available diagnostic tool, particularly to rule out PJI.
METHODS: We searched (from inception to November 2023) MEDLINE, Scopus, EMBASE, Web of Science, and Cochrane for studies on calprotectin in the diagnosis of periprosthetic joint infection (PJI). Sensitivity, specificity, positive and negative likelihood ratio (LR), and diagnostic odds ratio were analyzed. The receiver-operating curve for each method was calculated.
RESULTS: We included 14 articles in our meta-analysis, including 902 patients who underwent total hip and knee arthroplasties revision; 331 (37%) had a joint infection according to MSIS, MSIS-modified criteria, ICM 2018 and EBJIS 2021. Considering the false-positive result rate of 6% and false-negative result rate of 7%, pooled sensitivity and specificity were 0.92 (95% CI 0.89-0.94) and 0.93 (0.91-0.95), respectively. The area under the curve (AUC) was 0.93 (95% CI 0.91-0.94). No statistical differences in terms of sensitivity and specificity were found between ELISA and LFT. The pooled sensitivity and specificity of the two calprotectin assessment methods were: LFT 0.90 (95% CI 0.869-0.935) and 0.92 (95% CI 0.894-0.941), respectively; ELISA 0.96 (95% CI 0.914-0.986) and 0.97 (95% CI 0.934-0.988), respectively. The diagnostic odds ratio of the ELISA was superior to that of the LFT (906.6667, 95% CI 271.2686-3030.3712 versus 113.8886, 95% CI 70.4001-184.2414; p < 0.001). The AUC for ELISA and LFT was 0.968 (95% CI 0.944-0.984) and 0.915 (95% CI 0.895-0.933), respectively.
CONCLUSIONS: Detection of synovial calprotectin is an accurate test for diagnosis of hip and knee prosthetic infections. The diagnostic accuracy of the two calprotectin assessment methods is almost comparable. The LFT is a valid, rapid, and more available diagnostic tool, particularly to rule out PJI.
摘要：
背景：钙卫蛋白是一种具有抗菌特性的蛋白质，使其成为感染的独特标记。目前有两种方法可用于钙卫蛋白的测定：酶联免疫吸附测定（ELISA）和侧流试验（LFT）。我们旨在评估滑液钙卫蛋白的诊断准确性，并比较基于实验室的测试和定性评估对髋关节和膝关节假体感染诊断的准确性。
方法：我们搜索了（从成立到2023年11月）MEDLINE，Scopus,EMBASE,WebofScience,和Cochrane用于钙卫蛋白在假体周围感染（PJI）诊断中的研究。灵敏度,特异性，正负似然比(LR)，并对诊断比值比进行分析。计算每种方法的接受者操作曲线。
结果：我们在荟萃分析中纳入了14篇文章，包括902例接受全髋和膝关节置换术的患者；根据MSIS，331例（37％）有关节感染，MSIS修改的标准，ICM2018和EBJIS2021。考虑到6％的假阳性结果率和7％的假阴性结果率，合并敏感性和特异性分别为0.92(95%CI0.89-0.94)和0.93(0.91-0.95)，分别。曲线下面积(AUC)为0.93(95%CI0.91-0.94)。ELISA和LFT之间在灵敏度和特异性方面没有发现统计学差异。两种钙卫蛋白评估方法的合并敏感性和特异性为：LFT0.90（95％CI0.869-0.935）和0.92（95％CI0.894-0.941），ELISA分别为0.96（95%CI0.914-0.986）和0.97（95%CI0.934-0.988），分别。ELISA的诊断比值比优于LFT（906.6667，95％CI271.2686-3030.3712与113.8886，95％CI70.4001-184.2414；p<0.001）。ELISA和LFT的AUC为0.968（95％CI0.944-0.984）和0.915（95％CI0.895-0.933），分别。
结论：检测滑膜钙卫蛋白是诊断髋关节和膝关节假体感染的准确检测方法。两种钙卫蛋白评估方法的诊断准确性几乎相当。LFT是有效的，快速,和更多可用的诊断工具，特别是排除PJI。
方法：我们搜索了（从成立到2023年11月）MEDLINE，Scopus,EMBASE,WebofScience,和Cochrane用于钙卫蛋白在假体周围感染（PJI）诊断中的研究。灵敏度,特异性，正负似然比(LR)，并对诊断比值比进行分析。计算每种方法的接受者操作曲线。
结果：我们在荟萃分析中纳入了14篇文章，包括902例接受全髋和膝关节置换术的患者；根据MSIS，331例（37％）有关节感染，MSIS修改的标准，ICM2018和EBJIS2021。考虑到6％的假阳性结果率和7％的假阴性结果率，合并敏感性和特异性分别为0.92(95%CI0.89-0.94)和0.93(0.91-0.95)，分别。曲线下面积(AUC)为0.93(95%CI0.91-0.94)。ELISA和LFT之间在灵敏度和特异性方面没有发现统计学差异。两种钙卫蛋白评估方法的合并敏感性和特异性为：LFT0.90（95％CI0.869-0.935）和0.92（95％CI0.894-0.941），ELISA分别为0.96（95%CI0.914-0.986）和0.97（95%CI0.934-0.988），分别。ELISA的诊断比值比优于LFT（906.6667，95％CI271.2686-3030.3712与113.8886，95％CI70.4001-184.2414；p<0.001）。ELISA和LFT的AUC为0.968（95％CI0.944-0.984）和0.915（95％CI0.895-0.933），分别。
结论：检测滑膜钙卫蛋白是诊断髋关节和膝关节假体感染的准确检测方法。两种钙卫蛋白评估方法的诊断准确性几乎相当。LFT是有效的，快速,和更多可用的诊断工具，特别是排除PJI。
