Favalli Cartesio, Favaro Marco, Santi Flavia, Piperno Micol, D'Agostini Cartesio, Ciotti Marco
Department of Clinical Microbiology and Virology, Polyclinic Tor Vergata Foundation, Rome, Italy.
Department of Biochemical Sciences, Catholic University "Our Lady of Good Counsel", Tirana, Albania.
Eurasian J Med. 2019 Feb;51(1):5-7. doi: 10.5152/eurasianjmed.2018.17364. Epub 2018 Nov 30.
To evaluate the performance of the culture colorimetric detection assay MYCO WELL D-ONE (MWD-ONE), designed to detect sexually transmitted infections using real-time polymerase chain reaction (PCR) as a reference method.
One hundred and ten urogenital samples were screened for (GV), (TV), (MH), , and (UU)/ (UP) using the MWD-ONE and real-time PCR assays species Real-TM Quant and Anyplex II STI-7 Detection, respectively.
GV was detected in 33 samples by both the MWD-ONE and real-time PCR, while 6 samples gave discordant results. TV was detected by both MWD-ONE and Anyplex II STI-7 Detection kits in 3 samples, while 107 were negative. MH was detected by both methods in 5 cases, 4 samples gave discordant results, and 101 were negative. (MG) was detected by Anyplex II STI-7 in 2 cases, 1 of which was detected as by MWD-ONE. Ten samples were positive by MWD-ONE, and 98 were negative with both assays. With regard to 24 cases were detected by MWD-ONE and Anyplex PCR, 25 by PCR only, 4 by MWD-ONE, and 57 tested negative with both methods.The positive predictive values (PPV) and negative predictive values (NPV) of the MWD-ONE assay for the pathogens tested were as following: GV, PPV 94.3%, NPV 94.7%; TV, PPV and NPV 100%; MH, PPV 71.4%, NPV 98.1%; PPV 9.1%, NPV 98.9%; and PPV 85.7 %, NPV 69.5 %. The agreement between the MWD-ONE and PCR was strong for GV and MH (k=0.8 and 0.7, respectively); perfect for TV (k=1); and moderate for UU/UP (k=0.4).
MWD-ONE assay appears to be suitable for routine testing of sexually transmitted infections.
评估旨在使用实时聚合酶链反应（PCR）作为参考方法检测性传播感染的比色法检测试剂盒MYCO WELL D-ONE（MWD-ONE）的性能。
分别使用MWD-ONE和实时PCR检测试剂盒Real-TM Quant和Anyplex II STI-7 Detection对110份泌尿生殖系统样本进行筛查，检测解脲脲原体（UU）/生殖支原体（UP）、人型支原体（MH）、阴道毛滴虫（TV）、生殖支原体（MG）和加德纳菌（GV）。
MWD-ONE和实时PCR均在33份样本中检测到GV，6份样本结果不一致。MWD-ONE和Anyplex II STI-7检测试剂盒均在3份样本中检测到TV，107份为阴性。两种方法均在5例中检测到MH，4份样本结果不一致，101份为阴性。Anyplex II STI-7在2例中检测到生殖支原体（MG），其中1例MWD-ONE检测为解脲脲原体（UU）。MWD-ONE检测出10份样本呈阳性，两种检测方法均检测出98份样本为阴性。关于解脲脲原体（UU），MWD-ONE和Anyplex PCR检测出24例，仅PCR检测出25例，MWD-ONE检测出4例，两种方法均检测出57例为阴性。MWD-ONE检测所测病原体的阳性预测值（PPV）和阴性预测值（NPV）如下：GV，PPV 94.3%，NPV 94.7%；TV，PPV和NPV均为100%；MH，PPV 71.4%，NPV 98.1%；生殖支原体（MG），PPV 9.1%，NPV 98.9%；解脲脲原体（UU），PPV 85.7%，NPV 69.5%。MWD-ONE和PCR在GV和MH方面一致性较强（分别为k=0.8和0.7）；TV方面完全一致（k=1）；解脲脲原体（UU）/生殖支原体（UP）方面为中度一致（k=0.4）。
MWD-ONE检测似乎适用于性传播感染的常规检测。
