Tazi Sophia, Kabbaj Hakima, Zirar Jalila, Zouaki Amal, El Amin Ghizlane, El Himeur Othman, Seffar Myriam
Mohamed V University, Faculty of Medicine and Pharmacy, Rabat, Morocco.
Ibn Sina University Hospital Center, Central Laboratory of Virology, Rabat, Morocco.
Adv Virol. 2022 Jun 1;2022:4510900. doi: 10.1155/2022/4510900. eCollection 2022.
RT-PCR is the gold standard for COVID-19 diagnosis, but the lack of standardization of assays, whose diagnostic performance may widely vary, complicates the interpretation of the discrepancies that may be encountered. . We conducted a retrospective study over a ten-month period at the Central Laboratory of Virology of Ibn Sina University Hospital of Rabat. We included nasopharyngeal swabs, positive and negative for SARS-CoV-2 on FilmArray BioFire® Respiratory Panel 2.1 Plus, which were subjected to our laboratory's reference test, MAScIR SARS-CoV-2 M kit 2.0, initially or after a freeze-thaw cycle. The results were compared, and each discrepant sample with sufficient volume underwent the third test, using ARGENE® SARS-CoV-2 R-GENE kit.
Of 80 SARS-CoV-2 negative samples on FilmArray, there were no discordant results, whereas of 80 SARS-CoV-2 positive samples on FilmArray, 21 had discordant results on MAScIR, and only 11 could be tested on ARGENE, revealing positive results in 6 cases. 12.7% and 76.5% correspond to the discordance rates for MAScIR (with one or both targets detected on FilmArray), while 14.3% and 100% correspond to those of ARGENE. As the estimated sensitivity and specificity of FilmArray, compared with MAScIR, were 100% and 79.2%, respectively, its lower limit of detection, and ARGENE assay results, made it difficult to distinguish between false positives on FilmArray and false negatives on MAScIR without further investigations.
The implementation of a new assay in our laboratory revealed discrepancies suggesting a lack of sensitivity of our laboratory's reference test, leading us consequently to retain the SARS-CoV-2 positive result of these discordant samples on FilmArray, regardless of the detection of one or both targets. Our study, which is, to our knowledge, the first comparing FilmArray RP2.1 and MAScIR 2.0 assays for SARS-CoV-2 detection, highlights the urgent need to standardize RT-PCR assays for COVID-19 diagnosis.
逆转录聚合酶链反应（RT-PCR）是新冠病毒病（COVID-19）诊断的金标准，但检测方法缺乏标准化，其诊断性能可能差异很大，这使得对可能出现的差异结果的解读变得复杂。我们在拉巴特伊本·西那大学医院病毒学中央实验室进行了一项为期十个月的回顾性研究。我们纳入了在FilmArray BioFire® Respiratory Panel 2.1 Plus上对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）呈阳性和阴性的鼻咽拭子，这些拭子最初或经过冻融循环后接受了我们实验室的参考检测，即MAScIR SARS-CoV-2 M试剂盒2.0。对结果进行了比较，每个有足够体积的差异样本都使用ARGENE® SARS-CoV-2 R-GENE试剂盒进行了第三次检测。
在FilmArray上80份SARS-CoV-2阴性样本中，没有出现不一致的结果，而在FilmArray上80份SARS-CoV-2阳性样本中，有21份在MAScIR上出现了不一致的结果，只有11份能够在ARGENE上进行检测，其中6例显示为阳性结果。12.7%和76.5%分别对应MAScIR的不一致率（在FilmArray上检测到一个或两个靶点），而14.3%和100%分别对应ARGENE的不一致率。由于与MAScIR相比，FilmArray的估计灵敏度和特异性分别为100%和79.2%，其检测下限以及ARGENE检测结果使得在没有进一步调查的情况下，很难区分FilmArray上的假阳性和MAScIR上的假阴性。
我们实验室采用新检测方法的结果显示存在差异，这表明我们实验室的参考检测缺乏灵敏度，因此我们决定保留FilmArray上这些差异样本的SARS-CoV-2阳性结果，无论检测到一个还是两个靶点。据我们所知，我们的研究是首次比较FilmArray RP2.1和MAScIR 2.0检测方法对SARS-CoV-2的检测，突出了对COVID-19诊断的RT-PCR检测方法进行标准化的迫切需求。
