【摘要】 目的 评价一种国产新型耳念珠菌显色培养基的诊断效能。方法 使用了184株念珠菌，包括5株标准菌株、65株耳念珠菌、16株5种希木龙念珠菌复合体菌株、98株14种其他念珠菌临床株。使用国产耳念珠菌显色培养基（ATAU）进行菌种鉴定实验，以基质辅助激光解吸电离飞行时间质谱仪及核糖体DNA内转录间隔区分子测序为金标准进行诊断效能评价。此外，比较了ATAU与进口传统念珠菌显色琼脂培养基（CRCA）对常见念珠菌诊断效能的一致性，以及与进口新型耳念珠菌显色琼脂培养基（CRAU）对耳念珠菌-希木龙念珠菌复合体菌种鉴定能力的差异。结果 在35℃48 h培养条件下，与金标准鉴定结果相比，ATAU对耳念珠菌鉴定灵敏度为100%、特异度为97.4%、整体符合率98.3%。其中同属耳念珠菌-希木龙念珠菌复合体的1株东南亚念珠菌会被错误鉴定为耳念珠菌；另外假希木龙念珠菌的菌株虽呈现与耳念珠菌相似的颜色特征，但在35℃的培养温度下生长慢，所以可以进行区分；而在30℃下，亚希木龙念珠菌与希木龙念珠菌难以与耳念珠菌区分。此外，1株似平滑念珠菌（1/10）、1株近平滑念珠菌（1/10）被错误鉴定为耳念珠菌。ATAU与CRCA对白念珠菌、克柔念珠菌鉴定的灵敏度和特异度均为100%，二者一致率为100%；对热带念珠菌鉴定的灵敏度均为90.0%，特异度分别为100%、99.4%，两者都会漏检同一株热带念珠菌，但1株链状念珠菌（1/7）在CRCA上会错误鉴定为热带念珠菌；对光滑念珠菌鉴定的灵敏度均为100%,CRCA鉴定特异度为100%，但ATAU鉴定特异度为99.4%，原因是存在1株拟平滑念珠菌（1/10）会被错误鉴定。ATAU与CRAU均能准确检出耳念珠菌，对希木龙念珠菌复合体以及在ATAU上易错误鉴定的菌株的鉴定能力相似，对光滑念珠菌的鉴定特异性变低。结论 ATAU对耳念珠菌及临床常见念珠菌（白念珠菌、热带念珠菌、光滑念珠菌、克柔念珠菌）均有良好的诊断效能，与金标准的鉴定符合率均大于97%，特别针对耳念珠菌的灵敏度达到100%。该显色培养基适用于耳念珠菌的院感筛查及临床常见念珠菌的初步鉴定，为保证更为准确的报告，可辅以质谱鉴定的方法。更多还原

【Abstract】 Objective To assess the diagnostic performance of a novel domestic chromogenic medium for Candida auris. Methods This study utilized 184 Candida strains, including 5 reference strains, 65 strains of C. auris, 16 strains from 5 species of the C. haemulonii complex, and 98 clinical isolates of 14 other Candida species. Species identification was performed using a domestic C. auris chromogenic medium(ATAU), with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and ribosomal DNA internal transcribed spacer sequencing serving as gold standards. In addition, the consistency in diagnostic efficacy was compared between ATAU and imported traditional Candida chromogenic agar media(CRCA) for common Candida species. The difference in species identification capability was also assessed between ATAU and novel imported C. auris chromogenic agar media(CRAU) for the C. auris-C. haemulonii complex. Results Under the culture conditions of 35°C for 48 hours, compared with the results of the gold standard identification, the sensitivity of ATAU for the identification of C. auris was 100%, the specificity was 97.4%, and the overall coincidence rate was 98.3%. One strain of C. vulturna, which belongs to the C. auris-C. haemulonii complex, was misidentified as C. auris. In addition, the strains of C. pseudohaemulonii grow slowly at the culture temperature of 35°C even if their chromogenic features were similar to those of C. auris. Therefore, they can be distinguished. However, at 30°C, it was difficult to distinguish C. duobushaemulonii and C. haemulonii from C. auris. In addition, one strain each of C. metapsilosis(1/10) and one strain C. parapsilosis(1/10) were misidentified as C. auris. The sensitivity and specificity of both ATAU and CRCA for the identification of C. albicans and C. krusei were 100%, and the agreement rate between the two methods was 100%. The sensitivity of both methods was 90.0% for identification of C. tropicalis, and the specificity was 100% and 99.4%, respectively. Both methods missed the same strain of C. tropicalis, but one strain of C. catenulata(1/7) was misidentified as C. tropicalis on CRCA. The sensitivities of both methods were 100% for identification of C. glabrata. The identification specificity was 100% for CRCA, but 99.4% for ATAU, because a strain of C. orthopsilosis(1/10) was misidentified. Both ATAU and CRAU accurately detected C. auris, performed similarly in identifying the C. haemulonii complex and the strains that are easily misidentified on ATAU. It showed lower specificity in identifying C. glabrata. Conclusions ATAU has good diagnostic performance for C. auris and common Candida species(C. albicans, C. tropicalis, C. glabrata, C. krusei). The coincidence rate with the gold standard method is greater than 97%. Especially, the sensitivity for C. auris reaches 100%. Therefore, this chromogenic medium is suitable for the screening of nosocomial infections caused by C. auris and preliminary identification of common Candida species. However, identification based on mass spectrometry can be used to confirm the results of ATAU.更多还原