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The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3–7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8–27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.
Anwar M. Hashem; Rowa Y. Alhabbab; Abdullah Algaissi; Mohamed A. AlFaleh; Sharif Hala; Turki S. Abujamel; M-Zaki ElAssouli; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Almohanad A. Alkayyal; Ahmad Bakur Mahmoud; Naif A. M. Almontashiri; Arnab Pain. Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies. Pathogens 2020, 9, 1067 .
AMA StyleAnwar M. Hashem, Rowa Y. Alhabbab, Abdullah Algaissi, Mohamed A. AlFaleh, Sharif Hala, Turki S. Abujamel, M-Zaki ElAssouli, Afrah A. Al-Somali, Fadwa S. Alofi, Asim A. Khogeer, Almohanad A. Alkayyal, Ahmad Bakur Mahmoud, Naif A. M. Almontashiri, Arnab Pain. Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies. Pathogens. 2020; 9 (12):1067.
Chicago/Turabian StyleAnwar M. Hashem; Rowa Y. Alhabbab; Abdullah Algaissi; Mohamed A. AlFaleh; Sharif Hala; Turki S. Abujamel; M-Zaki ElAssouli; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Almohanad A. Alkayyal; Ahmad Bakur Mahmoud; Naif A. M. Almontashiri; Arnab Pain. 2020. "Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies." Pathogens 9, no. 12: 1067.
The Coronavirus Disease 2019 (COVID-19), caused by SARS-CoV-2, continues to spread globally with significantly high morbidity and mortality rates. Antigen-specific responses are of unquestionable value for clinical management of COVID-19 patients. Here, we investigated the kinetics of IgM, IgG against the spike (S) and nucleoproteins (N) proteins and their neutralizing capabilities in hospitalized COVID-19 patients with different disease presentations (i.e., mild, moderate or severe), need for intensive care units (ICU) admission or outcomes (i.e., survival vs death). We show that SARS-CoV-2 specific IgG, IgM and neutralizing antibodies (nAbs) were readily detectable in almost all COVID-19 patients with various clinical presentations. Interestingly, significantly higher levels of nAbs as well as anti-S1 and -N IgG and IgM antibodies were found in patients with more severe symptoms, patients requiring admission to ICU or those with fatal outcomes. More importantly, early after symptoms onset, we found that the levels of anti-N antibodies correlated strongly with disease severity. Collectively, these findings provide new insights into the kinetics of antibody responses in COVID-19 patients with different disease severity.
Anwar M. Hashem; Abdullah Algaissi; Sarah A. Almahboub; Mohamed A. Alfaleh; Turki S. Abujamel; Sawsan S. Alamri; Khalid A. Alluhaybi; Haya I. Hobani; Rahaf H. AlHarbi; Reem M. Alsulaiman; M-Zaki ElAssouli; Sharif Hala; Naif K. Alharbi; Rowa Y. Alhabbab; Ahdab A. AlSaieedi; Wesam H. Abdulaal; Abdullah Bukhari; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Arnab Pain; Almohanad A. Alkayyal; Naif A. M. Almontashiri; Ahmad Bakur Mahmoud; Xuguang Li. Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients. Viruses 2020, 12, 1390 .
AMA StyleAnwar M. Hashem, Abdullah Algaissi, Sarah A. Almahboub, Mohamed A. Alfaleh, Turki S. Abujamel, Sawsan S. Alamri, Khalid A. Alluhaybi, Haya I. Hobani, Rahaf H. AlHarbi, Reem M. Alsulaiman, M-Zaki ElAssouli, Sharif Hala, Naif K. Alharbi, Rowa Y. Alhabbab, Ahdab A. AlSaieedi, Wesam H. Abdulaal, Abdullah Bukhari, Afrah A. Al-Somali, Fadwa S. Alofi, Asim A. Khogeer, Arnab Pain, Almohanad A. Alkayyal, Naif A. M. Almontashiri, Ahmad Bakur Mahmoud, Xuguang Li. Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients. Viruses. 2020; 12 (12):1390.
Chicago/Turabian StyleAnwar M. Hashem; Abdullah Algaissi; Sarah A. Almahboub; Mohamed A. Alfaleh; Turki S. Abujamel; Sawsan S. Alamri; Khalid A. Alluhaybi; Haya I. Hobani; Rahaf H. AlHarbi; Reem M. Alsulaiman; M-Zaki ElAssouli; Sharif Hala; Naif K. Alharbi; Rowa Y. Alhabbab; Ahdab A. AlSaieedi; Wesam H. Abdulaal; Abdullah Bukhari; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Arnab Pain; Almohanad A. Alkayyal; Naif A. M. Almontashiri; Ahmad Bakur Mahmoud; Xuguang Li. 2020. "Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients." Viruses 12, no. 12: 1390.
The Coronavirus Disease 2019 (COVID-19), caused by the novel SARS-CoV-2, continues to spread globally with significantly high morbidity and mortality rates. Immunological surrogate markers, in particular antigen-specific responses, are of unquestionable value for clinical management of patients with COVID-19. Here, we investigated the kinetics of IgM, IgG against the spike (S) and nucleoproteins (N) proteins and their neutralizing capabilities in hospitalized patients with RT-PCR confirmed COVID-19 infection. Our data show that SARS-CoV-2 specific IgG, IgM and neutralizing antibodies (nAbs) were readily detectable in almost all COVID-19 patients with various clinical presentations. Notably, anti-S and -N IgG, peaked 20-40 day after disease onset, and were still detectable for at least up to 70 days, with nAbs observed during the same time period. Moreover, nAbs titers were strongly correlated with IgG antibodies. Significantly higher levels of nAbs as well as anti-S1 and N IgG and IgM antibodies were found in patients with more severe clinical presentations, patients requiring admission to intensive care units (ICU) or those with fatal outcomes. Interestingly, lower levels of antibodies, particularly anti-N IgG and IgM in the first 15 days after symptoms onset, were found in survivors and those with mild clinical presentations. Collectively, these findings provide new insights into the characteristics and kinetics of antibody responses in COVID-19 patients with different disease severity.
Anwar M Hashem; Abdullah Algaissi; Sarah A Almahboub; Mohamed A Alfaleh; Turki S Abujamel; Sawsan S Alamri; Khalid A Alluhaybi; Haya I Hobani; Rahaf H AlHarbi; Reem M Alsulaiman; M-Zaki ElAssouli; Sharif Hala; Naif K Alharbi; Rowa Y Alhabbab; Ahdab A AlSaieedi; Wesam H Abdulaal; Abdullah Bukhari; Afrah A Al-Somali; Fadwa S Alofi; Asim A Khogeer; Arnab Pain; Almohanad A Alkayyal; Naif Am Almontashiri; Ahmad Bakur Mahmoud; Xuguang Li. Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients. 2020, 1 .
AMA StyleAnwar M Hashem, Abdullah Algaissi, Sarah A Almahboub, Mohamed A Alfaleh, Turki S Abujamel, Sawsan S Alamri, Khalid A Alluhaybi, Haya I Hobani, Rahaf H AlHarbi, Reem M Alsulaiman, M-Zaki ElAssouli, Sharif Hala, Naif K Alharbi, Rowa Y Alhabbab, Ahdab A AlSaieedi, Wesam H Abdulaal, Abdullah Bukhari, Afrah A Al-Somali, Fadwa S Alofi, Asim A Khogeer, Arnab Pain, Almohanad A Alkayyal, Naif Am Almontashiri, Ahmad Bakur Mahmoud, Xuguang Li. Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients. . 2020; ():1.
Chicago/Turabian StyleAnwar M Hashem; Abdullah Algaissi; Sarah A Almahboub; Mohamed A Alfaleh; Turki S Abujamel; Sawsan S Alamri; Khalid A Alluhaybi; Haya I Hobani; Rahaf H AlHarbi; Reem M Alsulaiman; M-Zaki ElAssouli; Sharif Hala; Naif K Alharbi; Rowa Y Alhabbab; Ahdab A AlSaieedi; Wesam H Abdulaal; Abdullah Bukhari; Afrah A Al-Somali; Fadwa S Alofi; Asim A Khogeer; Arnab Pain; Almohanad A Alkayyal; Naif Am Almontashiri; Ahmad Bakur Mahmoud; Xuguang Li. 2020. "Early Humoral Response Correlates with Disease Severity and Outcomes in COVID-19 Patients." , no. : 1.
One-step RT-qPCR is the most widely applied method for COVID-19 diagnostics. Designing in-house one-step RT-qPCR kits is restricted by the patent-rights for the production of enzymes and the lack of information about the components of the commercial kits. Here, we provide a simple, economical, and powerful one-step RT-qPCR kit based on patent-free, specifically-tailored versions of Moloney Murine Leukemia Virus Reverse Transcriptase and Thermus aquaticus DNA polymerase termed the R3T (Rapid Research Response Team) One-step RT-qPCR. Our kit was routinely able to reliably detect as low as 10 copies of the synthetic RNAs of the SARS-CoV-2. More importantly, our kit successfully detected COVID-19 in clinical samples of broad viral titers with similar reliability and selectivity as that of the Invitrogen SuperScript III Platinum One-step RT-qPCR and TaqPath 1-Step RT-qPCR kits. Overall, our kit has shown robust performance in both of laboratory settings and the Saudi Ministry of Health-approved testing facility.
Masateru Takahashi; Muhammad Tehseen; Rahul Salunke; Etsuko Takahashi; Sara Mfarrej; Mohamed A. Sobhy; Fatimah Alhamlan; Sharif Hala; Gerardo R. Mandujano; Ahmed A. Al-Qahtani; Fadwa S. Alofi; Afrah Alsomali; Anwar M. Hashem; Asim Khogeer; Naif A. M. Almontashiri; Jae Man Lee; Hiroaki Mon; Kosuke Sakashita; Mo Li; Takahiro Kusakabe; Arnab Pain; Samir M. Hamdan. R3T (Rapid Research Response Team) One-step RT-qPCR kit for COVID-19 diagnostic using in-house enzymes. 2020, 1 .
AMA StyleMasateru Takahashi, Muhammad Tehseen, Rahul Salunke, Etsuko Takahashi, Sara Mfarrej, Mohamed A. Sobhy, Fatimah Alhamlan, Sharif Hala, Gerardo R. Mandujano, Ahmed A. Al-Qahtani, Fadwa S. Alofi, Afrah Alsomali, Anwar M. Hashem, Asim Khogeer, Naif A. M. Almontashiri, Jae Man Lee, Hiroaki Mon, Kosuke Sakashita, Mo Li, Takahiro Kusakabe, Arnab Pain, Samir M. Hamdan. R3T (Rapid Research Response Team) One-step RT-qPCR kit for COVID-19 diagnostic using in-house enzymes. . 2020; ():1.
Chicago/Turabian StyleMasateru Takahashi; Muhammad Tehseen; Rahul Salunke; Etsuko Takahashi; Sara Mfarrej; Mohamed A. Sobhy; Fatimah Alhamlan; Sharif Hala; Gerardo R. Mandujano; Ahmed A. Al-Qahtani; Fadwa S. Alofi; Afrah Alsomali; Anwar M. Hashem; Asim Khogeer; Naif A. M. Almontashiri; Jae Man Lee; Hiroaki Mon; Kosuke Sakashita; Mo Li; Takahiro Kusakabe; Arnab Pain; Samir M. Hamdan. 2020. "R3T (Rapid Research Response Team) One-step RT-qPCR kit for COVID-19 diagnostic using in-house enzymes." , no. : 1.
As the coronavirus disease 2019 (COVID-19), which is caused by the novel SARS-CoV-2, continues to spread rapidly around the world, there is a need for well validated serological assays that allow the detection of viral specific antibody responses in COVID-19 patients or recovered individuals. In this study, we established and used multiple indirect Enzyme Linked Immunosorbent Assay (ELISA)-based serological assays to study the antibody response in COVID-19 patients. In order to validate the assays we determined the cut off values, sensitivity and specificity of the assays using sera collected from pre-pandemic healthy controls, COVID-19 patients at different time points after disease-onset, and seropositive sera to other human coronaviruses. The developed SARS-CoV-2 S1 subunit of the spike glycoprotein and nucleocapsid (N)-based ELISAs not only showed high specificity and sensitivity but also did not show any cross-reactivity with other CoVs. We also show that all RT-PCR confirmed COVID-19 patients tested in our study developed both virus specific IgM and IgG antibodies as early as week one after disease onset. Our data also suggest that the inclusion of both S1 and N in serological testing would capture as many potential SARS-CoV-2 positive cases as possible than using any of them alone. This is specifically important for tracing contacts and cases and conducting large-scale epidemiological studies to understand the true extent of virus spread in populations.
Abdullah Algaissi; Mohamed A. AlFaleh; Sherif Hala; Turki S. Abujamel; Sawsan S. Alamri; Sarah A Almahboub; Khalid A. Alluhaybi; Haya I. Hobani; Reem M. Alsulaiman; Rahaf H. Alharbi; M-Zaki El-Assouli; Rowa Y Alhabbab; Ahdab A. AlSaieedi; Wesam H. Abdulaal; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Ahmad Bakur Mahmoud; Almohanad A Alkayyal; Naif A.M. Almontashiri; Arnab Pain; Anwar M. Hashem. SARS-CoV-2 S1 and N-Based Serological Assays Reveal Rapid Seroconversion and Induction of Specific Antibody Response in COVID-19 Patients. 2020, 1 .
AMA StyleAbdullah Algaissi, Mohamed A. AlFaleh, Sherif Hala, Turki S. Abujamel, Sawsan S. Alamri, Sarah A Almahboub, Khalid A. Alluhaybi, Haya I. Hobani, Reem M. Alsulaiman, Rahaf H. Alharbi, M-Zaki El-Assouli, Rowa Y Alhabbab, Ahdab A. AlSaieedi, Wesam H. Abdulaal, Afrah A. Al-Somali, Fadwa S. Alofi, Asim A. Khogeer, Ahmad Bakur Mahmoud, Almohanad A Alkayyal, Naif A.M. Almontashiri, Arnab Pain, Anwar M. Hashem. SARS-CoV-2 S1 and N-Based Serological Assays Reveal Rapid Seroconversion and Induction of Specific Antibody Response in COVID-19 Patients. . 2020; ():1.
Chicago/Turabian StyleAbdullah Algaissi; Mohamed A. AlFaleh; Sherif Hala; Turki S. Abujamel; Sawsan S. Alamri; Sarah A Almahboub; Khalid A. Alluhaybi; Haya I. Hobani; Reem M. Alsulaiman; Rahaf H. Alharbi; M-Zaki El-Assouli; Rowa Y Alhabbab; Ahdab A. AlSaieedi; Wesam H. Abdulaal; Afrah A. Al-Somali; Fadwa S. Alofi; Asim A. Khogeer; Ahmad Bakur Mahmoud; Almohanad A Alkayyal; Naif A.M. Almontashiri; Arnab Pain; Anwar M. Hashem. 2020. "SARS-CoV-2 S1 and N-Based Serological Assays Reveal Rapid Seroconversion and Induction of Specific Antibody Response in COVID-19 Patients." , no. : 1.