Hunan Provincial Center for Disease Control and Prevention, Changsha City, China.
Shanghai Changning District Center for Disease Control and Prevention, Shanghai, China.
Int J Infect Dis. 2020 Oct;99:414-420. doi: 10.1016/j.ijid.2020.08.020. Epub 2020 Aug 13.
To compare the performance of two syndromic panels: Luminex xTAG Gastrointestinal Pathogen Panel (GPP) and FilmArray Gastrointestinal (GI) panel.
A total of 243 diarrhea specimens were detected by two panels in parallel, and the inconsistent results were analyzed by real-time PCR or reverse transcription PCR (RT-PCR). The target concentration in specimens was examined by comparing the crossing point values of FilmArray, the median fluorescence intensity of xTAG and the cycle threshold values in any discrepancies.
For pathogens detected by both panels, the positive rates of FilmArray GI and xTAG GPP were 65.0% and 48.6%, respectively. The two panels showed high consistency (kappa ≥0.74) in detecting norovirus, rotavirus and Campylobacter, while there was low consistency (kappa ≤0.40) in detecting Cryptosporidium, Salmonella, Shiga toxin-producing Escherichia coli (STEC) and enterotoxigenic Escherichia coli (ETEC). Samples with low concentration targets were more often detected by FilmArray than with xTAG GPP. The xTAG GPP was more likely to be affected by amplification inhibitors. Several defects of xTAG GPP were found in detecting ETEC.
FilmArray was more sensitive. For specimens with low target concentrations or containing ETEC heat stable enterotoxin, the false negatives of xTAG GPP need to be considered.
比较两种症候群检测试剂盒的性能：Luminex xTAG 胃肠道病原体检测试剂盒（GPP）和 FilmArray GI 试剂盒。
通过平行检测的方式，对 243 份腹泻样本进行了两种试剂盒的检测，对不一致的结果通过实时 PCR 或反转录 PCR（RT-PCR）进行分析。通过比较 FilmArray 的检测交叉点值、xTAG 的中位荧光强度以及任何差异中的循环阈值，来检测样本中的目标浓度。
对于两种试剂盒都检测到的病原体，FilmArray GI 和 xTAG GPP 的阳性率分别为 65.0%和 48.6%。两种试剂盒在检测诺如病毒、轮状病毒和弯曲杆菌方面具有高度一致性（kappa ≥0.74），而在检测隐孢子虫、沙门氏菌、产志贺毒素大肠杆菌（STEC）和肠毒性大肠杆菌（ETEC）方面一致性较低（kappa ≤0.40）。低浓度目标样本更常被 FilmArray 检测到，而不是 xTAG GPP。xTAG GPP 更容易受到扩增抑制剂的影响。在检测 ETEC 时，发现 xTAG GPP 存在几个缺陷。
FilmArray 更为敏感。对于低浓度目标样本或含有 ETEC 耐热肠毒素的样本，需要考虑 xTAG GPP 的假阴性。
