The three of them were included in the global evaluation of Sienna? and Wondfo? and one was included in the evaluation of Prometheus?. The 20 serum samples from 2018 included as negative control of Sienna? and Prometheus? resulted in one positive sample with an IgM band using Sienna? while seven were positive (2 IgG and IgM, 3 IgG and 2 IgM) with Prometheus?. Discussion Diagnosis of SARS-CoV-2 remains challenging in most fields. test for Sienna?, Wondfo? and Prometheus? was 67.6%, 59% and 47.2%, with a prevalence of COVID-19 of 69.7%, PND-1186 62.4% and 55.1% respectively. Sensitivity of the three assessments (Sienna?, Wondfo? and Prometheus? respectively) along the three different stages was 36.6%, 18.8% and 68.6% in the early stage (first week); 81.3%, 74.1% and 90.9% in the intermediate stage (second week) and 100%, 83.3% and 100% in the late stage (third week). The results demonstrate that even though Prometheus? presented a high sensitivity, the specificity was notably lower than the other two assessments. Sienna? showed the greatest contrast between sensitivity and specificity, PND-1186 achieving the best accuracy, followed by Wondfo?. The sensitivity of the three ICT assays was higher in late stages of the disease. Electronic supplementary material The online version of this article (10.1007/s10096-020-04010-7) contains supplementary material, which is available to authorized users. strong class=”kwd-title” Keywords: SARS-CoV-2, COVID-19, Serology, Lateral circulation immunoassays, Immunochromatographic strip assay Introduction In late December 2019, a novel coronavirus was identified as the etiological agent of anew pneumonia [1, 2]. The etiological agent, named as SARS-CoV-2, rapidly spread to other cities PND-1186 in China and to other countries worldwide and on 11 March World Health Business (WHO) declared the outbreak as a pandemic. This situation has forced many countries to adopt firm measures in order to promote early detection of COVID-19 and early isolation of the cases, track contacts and encourage distancing steps. Real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) has been established as the platinum standard for microbiological PND-1186 diagnostic of SARS-CoV-2 contamination, targeting at least two different regions of SARS-Cov-2 genome in order to avoid cross-reactivity with other coronavirus and the potential genetic drift of SARS-CoV-2 [3C6]. RT-qPCR assessments presented a high specificity with a low probability of false positive; however, sensitivity relies on different factors as specimen site, method of collection, viral weight and time from your onset of symptoms [3, 7]. An increasing number of cases with unfavorable RT-qPCR and clinical features consistent with COVID-19 pneumonia has been reported [8C10].Therefore, supplementary diagnostic approaches are needed to reduce the quantity of false-negative cases, which is essential for Rabbit polyclonal to ALS2 the epidemiologic control of the disease . Several studies focused on antibody response against SARS-CoV-2 suggested that IgM can be detected during the first week since the onset of the symptoms, even though IgM detection rate is usually highly variable at this early stage [12C14]. IgG can be detectable after 8?days since the onset of the symptoms, and after 14?days, over 90% of cases present antibodies against SARS-CoV-2 [13C15]. However, the strength of antibody response depends on several factors (nutritional state, severity of disease, immune status…) and it has been observed that some patients do not produce detectable levels of antibodies [13, 15, 16]. Therefore, serological methods had limited utility for early diagnosis of COVID-19, since the sensitivity of the assay is low during the first days and increases with time. However, serologic tests could play an important role in confirmation and late diagnostic of COVID-19, mainly in patients with repetitive negative RT-qPCR, as well as giving information about the immune status of asymptomatic patients and contributing to the determination of the prevalence and mortality rate . Combination of RT-qPCR and IgM/IgG detection methods could provide a suitable approach to COVID-19 diagnosis . Several studies suggested that acquired immunity is protective against SARS-CoV2 re-infection [19, 20], though some reports described cases of post-recovery positive nasopharyngeal RT-qPCR [21C23]. Currently, is being discussed if the recurrence of positive SARS-CoV-2 RT-qPCR in recovered patients with subsequent negative RT-qPCR is due to prolonged viral shedding with false negative results of RT-qPCR, or a possible re-infection [21, 24, 25]. In this context, the use of serologic test for the follow-up of the immune response in.