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Evaluation of Rapid Antibody Test Compatibility in COVID-19 Cases Confirmed by RT-PCR Assay

Year 2024, Volume: 8 Issue: 2, 57 - 64, 31.08.2024
https://doi.org/10.33716/bmedj.1440843

Abstract

Aim: This study aimed to determine the reliability of rapid antibody detection test (RADT; Weimi Bio-Tech COVID-19 Antibody test) results and their compatibility with RT-PCR test in screening and control of COVID-19 infection.
Material and Methods: Our study was conducted with the permission of the Ministry of Health and the local ethics committee of our hospital. Laboratory results of 624 healthcare personnel were recorded between May 2020 and November 2020. Two nasopharyngeal specimens were collected from each case to perform RT-PCR. Simultaneously serum/plasma samples were collected for RADT testing. Our hospital's data processing system (HIS) and laboratory information system (LIS) records were used for data collection. The level of agreement between the tests was calculated using Cohen's κ index. Statistical analyses were performed using SPSS software.
Results: The mean age of the patients included in the study was 28.46 ± 2.35 years. Of all cases, 54% were female (n=337) and 46% (n=287) were male, and none of the cases had any comorbidity. Both RT-PCR and RADT were negative in 86% of the cases (n=540). RT-PCR results were positive in 13.6% (n=102) of the included cases. Of the 102 RT-PCR positive cases, 84 were positive by RADT and there were no false positive results with RADT. Sensitivity and specificity for all cases were 84.7% and 100%, respectively. In symptomatic cases, sensitivity was >95%. Conclusion: We consider that antibody tests may be useful in screening for COVID-19 in circumstances where access to RT_PCR testing may be limited, particularly in cases in the first or second week of symptomatic infection.

References

  • Dortet, L., Ronat, J.-B., Vauloup-Fellous, C., Langendorf, C., Mendels, D.-A., Emeraud, C., Oueslati, S., Girlich, D., Chauvin, A., & Afdjei, A. (2021). Evaluating 10 commercially available SARS-CoV-2 rapid serological tests by use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) method. Journal of clinical microbiology, 59(2), 10.1128/jcm. 02342-02320.
  • Kaçmaz, A. B., Sümbül, B., Bolukcu, S., Okay, G., Durdu, B., Akkoyunlu, Y., & Koç, M. M. (2020). Utility of Rapid Antibody Test for Screening COVID-19 among Healthcare Professionals.
  • Lawandi, A., & Danner, R. L. (2020). Antibody tests have higher sensitivity at≥ 15 days after symptom onset and 99% specificity for detecting SARS-CoV-2. Annals of internal medicine, 173(10), JC57.
  • Masiá, M., Fernández-González, M., Sánchez, M., Carvajal, M., García, J. A., Gonzalo-Jiménez, N., Ortiz de la Tabla, V., Agulló, V., Candela, I., & Guijarro, J. (2021). Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infectious Diseases,
  • McAloon, C., Collins, Á., Hunt, K., Barber, A., Byrne, A. W., Butler, F., Casey, M., Griffin, J., Lane, E., & McEvoy, D. (2020). Incubation period of COVID-19: a rapid systematic review and meta-analysis of observational research. BMJ open, 10(8), e039652.
  • Mina, M. J., Parker, R., & Larremore, D. B. (2020). Rethinking Covid-19 test sensitivity—a strategy for containment. New England Journal of Medicine, 383(22), 120.
  • Sabat, J., Subhadra, S., Rath, S., Ho, L. M., Satpathy, T., Pattnaik, D., Pati, S., & Turuk, J. (2023). A comparison of SARS-CoV-2 rapid antigen testing with realtime RT-PCR among symptomatic and asymptomatic individuals. BMC Infectious Diseases, 23(1), 87.
  • Santos, R. E. A., da Silva, M. G., do Monte Silva, M. C. B., Barbosa, D. A. M., do Vale Gomes, A. L., Galindo, L. C. M., da Silva Aragão, R., & Ferraz-Pereira, K. N. (2021). Onset and duration of symptoms of loss of smell/taste in patients with COVID-19: A systematic review. American Journal of Otolaryngology, 42(2), 102889.
  • Sethuraman, N., Jeremiah, S. S., & Ryo, A. (2020). Interpreting diagnostic tests for SARS-CoV-2. Jama, 323(22), 2249-2251.
  • Sidiq, Z., Hanif, M., Dwivedi, K. K., & Chopra, K. (2020). Benefits and limitations of serological assays in COVID-19 infection. indian journal of tuberculosis, 67(4), S163-S166.
  • Tanrıverdi Çaycı, Y., Seyfi, Z., Hacieminoglu Ulker, K., Gür Vural, D., Bilgin, K., Akdemir, H., Akyüz Özkan, E., & Birinci, A. (2023). Evaluation of Rapid Antigen Test Results and Real-time Reverse Transcription Polymerase Chain Reaction for the Laboratory Diagnosis of SARS-CoV-2. Mediterranean Journal Of Infection Microbes And Antimicrobials.
  • Yuan, X., Yang, C., He, Q., Chen, J., Yu, D., Li, J., Zhai, S., Qin, Z., Du, K., & Chu, Z. (2020). Current and perspective diagnostic techniques for COVID-19. ACS infectious diseases, 6(8), 1998-2016.
  • Zhao, J., Yuan, Q., Wang, H., Liu, W., Liao, X., Su, Y., Wang, X., Yuan, J., Li, T., & Li, J. (2020). Antibody responses to SARS-CoV-2 in patients with novel coronavirus disease 2019. Clinical infectious diseases, 71(16), 2027-2034.

RT-PCR Testi ile doğrulanmış COVID-19 olgularında hızlı antikor testi uyumluluğunun değerlendirilmesi

Year 2024, Volume: 8 Issue: 2, 57 - 64, 31.08.2024
https://doi.org/10.33716/bmedj.1440843

Abstract

INTRODUCTION: It was aimed to determine the reliability of rapid antibody detection test (RADT) results and compatibility with RT-PCR assay in the screening and control of COVID-19 infection.
METHODS: The retrospective study was performed with the permission of the Ministry of Health and the local ethics committee of our hospital. Between May 2020 and August 2021, 624 health staffs laboratory results were recorded. Data processing hospital (HIS) and laboratory information system (LIS) records of our hospital were used as data collection method. The level of agreement between tests was estimated using Cohen's κ index. Statistical analyzes were performed using SPSS open source software.
RESULTS: The mean age of the participants in the study was 28,46 ± 2,35. 54% were female (337), 46% (n=287) were male, and they had no additional disease. Both rapid antibody testing and RT-PCR tests were negative in 86% (n=540) of all tests. Two nasopharyngeal specimens were collected from each case to perform the RADT and RT-PCR. 13,6% (n=102) of the included patients had positive RT-PCR results. The RADT detected 84 of the 102 RT-PCR-positive cases and there were no false positive results. Overall sensitivity and specificity were 84,7% and 100%, respectively. Sensitivity was found >95% in symptomatic cases.
DISCUSSION AND CONCLUSION: The Weimi Bio-Tech COVID-19 Ag RADT can be useful in screening for COVID-19, especially in cases in the first or second weeks of symptomatic infection.

Ethical Statement

Dear Editor, We would like to submit the attached manuscript, “Evaluation of rapid antibody test compatibility in COVID-19 cases confirmed by RT-PCR assey ” for consideration for possible publication in Sürekli Tıp Eğitimi Dergisi (STED) The approval from local educational research committee was taken prio to study. We would like to undertake that the mentioned manuscript has not been published elsewhere, accepted for publication elsewhere. Each author participated sufficiently in the work to take public responsibility for appropriate portions of the content of the manuscript. The authors declare that they have no potential conflict of interest. Please let me know of your decision at your earliest convenience. With my best regards, Asuman Akkaya Fırat

Supporting Institution

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Thanks

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References

  • Dortet, L., Ronat, J.-B., Vauloup-Fellous, C., Langendorf, C., Mendels, D.-A., Emeraud, C., Oueslati, S., Girlich, D., Chauvin, A., & Afdjei, A. (2021). Evaluating 10 commercially available SARS-CoV-2 rapid serological tests by use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) method. Journal of clinical microbiology, 59(2), 10.1128/jcm. 02342-02320.
  • Kaçmaz, A. B., Sümbül, B., Bolukcu, S., Okay, G., Durdu, B., Akkoyunlu, Y., & Koç, M. M. (2020). Utility of Rapid Antibody Test for Screening COVID-19 among Healthcare Professionals.
  • Lawandi, A., & Danner, R. L. (2020). Antibody tests have higher sensitivity at≥ 15 days after symptom onset and 99% specificity for detecting SARS-CoV-2. Annals of internal medicine, 173(10), JC57.
  • Masiá, M., Fernández-González, M., Sánchez, M., Carvajal, M., García, J. A., Gonzalo-Jiménez, N., Ortiz de la Tabla, V., Agulló, V., Candela, I., & Guijarro, J. (2021). Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age. Open Forum Infectious Diseases,
  • McAloon, C., Collins, Á., Hunt, K., Barber, A., Byrne, A. W., Butler, F., Casey, M., Griffin, J., Lane, E., & McEvoy, D. (2020). Incubation period of COVID-19: a rapid systematic review and meta-analysis of observational research. BMJ open, 10(8), e039652.
  • Mina, M. J., Parker, R., & Larremore, D. B. (2020). Rethinking Covid-19 test sensitivity—a strategy for containment. New England Journal of Medicine, 383(22), 120.
  • Sabat, J., Subhadra, S., Rath, S., Ho, L. M., Satpathy, T., Pattnaik, D., Pati, S., & Turuk, J. (2023). A comparison of SARS-CoV-2 rapid antigen testing with realtime RT-PCR among symptomatic and asymptomatic individuals. BMC Infectious Diseases, 23(1), 87.
  • Santos, R. E. A., da Silva, M. G., do Monte Silva, M. C. B., Barbosa, D. A. M., do Vale Gomes, A. L., Galindo, L. C. M., da Silva Aragão, R., & Ferraz-Pereira, K. N. (2021). Onset and duration of symptoms of loss of smell/taste in patients with COVID-19: A systematic review. American Journal of Otolaryngology, 42(2), 102889.
  • Sethuraman, N., Jeremiah, S. S., & Ryo, A. (2020). Interpreting diagnostic tests for SARS-CoV-2. Jama, 323(22), 2249-2251.
  • Sidiq, Z., Hanif, M., Dwivedi, K. K., & Chopra, K. (2020). Benefits and limitations of serological assays in COVID-19 infection. indian journal of tuberculosis, 67(4), S163-S166.
  • Tanrıverdi Çaycı, Y., Seyfi, Z., Hacieminoglu Ulker, K., Gür Vural, D., Bilgin, K., Akdemir, H., Akyüz Özkan, E., & Birinci, A. (2023). Evaluation of Rapid Antigen Test Results and Real-time Reverse Transcription Polymerase Chain Reaction for the Laboratory Diagnosis of SARS-CoV-2. Mediterranean Journal Of Infection Microbes And Antimicrobials.
  • Yuan, X., Yang, C., He, Q., Chen, J., Yu, D., Li, J., Zhai, S., Qin, Z., Du, K., & Chu, Z. (2020). Current and perspective diagnostic techniques for COVID-19. ACS infectious diseases, 6(8), 1998-2016.
  • Zhao, J., Yuan, Q., Wang, H., Liu, W., Liao, X., Su, Y., Wang, X., Yuan, J., Li, T., & Li, J. (2020). Antibody responses to SARS-CoV-2 in patients with novel coronavirus disease 2019. Clinical infectious diseases, 71(16), 2027-2034.
There are 13 citations in total.

Details

Primary Language English
Subjects Clinical Microbiology
Journal Section RESEARCH ARTICLE
Authors

Asuman Akkaya Fırat 0000-0001-7338-3282

Haluk Kılıç 0000-0002-3222-0601

Serkan Elarslan 0000-0001-6386-4525

Ümit Bilgili 0000-0002-5301-9982

Hanife Aydın Yazıcılar 0000-0001-6954-0580

Ebru Tarıkçı Kılıç 0000-0002-5377-1090

Uğur Ayan 0000-0003-3567-0656

Early Pub Date August 30, 2024
Publication Date August 31, 2024
Submission Date February 22, 2024
Acceptance Date June 10, 2024
Published in Issue Year 2024 Volume: 8 Issue: 2

Cite

APA Akkaya Fırat, A., Kılıç, H., Elarslan, S., Bilgili, Ü., et al. (2024). Evaluation of Rapid Antibody Test Compatibility in COVID-19 Cases Confirmed by RT-PCR Assay. Balıkesir Medical Journal, 8(2), 57-64. https://doi.org/10.33716/bmedj.1440843