The Effect of Correlation of Laboratory-Developed Test and Initial Symptoms and False Negatives in RT-PCR Strategies for COVID-19 Patients with Beta Variants

S. Ghasemi, S. Nadji, M. Dashti, M. Karimi-Galougahi, Negar Raygani, Mahla Nabi, Ghazal Mohammadi, Niyoosha Kandez, Amirali Ebrahimi, Elaheh Askari
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Abstract

Abstract Background  Reverse transcription-polymerase chain reaction (RT-PCR) assays detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of viruses in the sample varies between patients; it depends on sample location, nasal or throat, and with time infection spreads. Previous studies showed that the viral load of coronavirus disease 2019 (COVID-19) infection is the peak just before symptoms onset. Furthermore, positive and negative results depend on test site, sampling, and timing method; RT-PCR can be 1 to 30% false-negative result. Methods and Materials  Within this study, we took RT-PCR test from COVID-19 positive patients who already had the confirmation of the disease either by lung computed tomography (CT)-scan or the symptoms such as dyspnea. The study was explained to all the patients, and they confirmed to take the RT-PCR test. Negative samples from those patients were retested, and if the result came back negative, we included them as negative in the result. Result  A total number of 49 patients (25 females) and (24 males) with a mean age of 53.24 years (ranging from 32 to 77) were enrolled. About 32.3% of patients, despite having COVID-19 disease, had a negative RT-PCR test. There is a positive and significant relationship between weight ( r  = 0.253) and CT at the time of hospitalization of COVID-19 patients and a negative and significant relationship with O2 saturation without oxygen therapy ( r  =  − 0.296), the model can predict 67.7% of the disease due to the beta value, and the share of O2 saturation without oxygen therapy is more than weight. Conclusion  We show that a pragmatic model can be designed to predict which patients have a higher chance of getting false-negative result, and should be retested for COVID-19. Among the variables, weight had a negative and significant relationship, and O2 saturation without respiratory support had a negative and significant relationship with COVID-19 disease.
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实验室开发的测试与初始症状和假阴性在RT-PCR策略中的相关性对COVID-19 β变异体患者的影响
背景逆转录聚合酶链反应(RT-PCR)检测严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)。样本中的病毒数量因患者而异;它取决于样本的位置,鼻腔或喉咙,随着时间的推移感染会扩散。此前的研究表明,COVID-19感染的病毒载量在症状出现前达到峰值。此外,阳性和阴性结果取决于测试地点、采样和定时方法;RT-PCR可产生1 ~ 30%的假阴性结果。方法和材料在本研究中,我们对已经通过肺部计算机断层扫描(CT)或呼吸困难等症状确诊的COVID-19阳性患者进行了RT-PCR检测。向所有患者解释了该研究,并确认进行RT-PCR检测。这些患者的阴性样本被重新检测,如果结果为阴性,我们将其纳入阴性结果。结果共纳入49例患者,其中女性25例,男性24例,平均年龄53.24岁,年龄32 ~ 77岁。约32.3%的患者尽管患有COVID-19疾病,但RT-PCR检测结果为阴性。COVID-19患者住院时体重与CT呈显著正相关关系(r = 0.253),与不进行氧疗的O2饱和度呈显著负相关关系(r = - 0.296),由于beta值的存在,该模型可以预测67.7%的疾病,且不进行氧疗的O2饱和度所占比例大于体重。结论可以设计一个实用的模型来预测哪些患者假阴性的可能性更高,哪些患者应该重新进行COVID-19检测。其中,体重与COVID-19疾病呈显著负相关,无呼吸支持的血氧饱和度与COVID-19疾病呈显著负相关。
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