VALIDATION OF ANTIBODY RAPID TEST FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 INFECTION IN BETHESDA HOSPITAL YOGYAKARTA

Fenty Fenty; Ivan Lim; Frida E. W.; Kristiani D.; Rizaldi Pinzon

doi:10.24071/jpsc.002973

VALIDATION OF ANTIBODY RAPID TEST FOR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS-2 INFECTION IN BETHESDA HOSPITAL YOGYAKARTA

Fenty Fenty, Ivan Lim, Frida E. W., Kristiani D., Rizaldi Pinzon

Abstract

Since March 2020, Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection has been around in Indonesia with a case fatality rate was 4.7% on August, 1th 2020. So far, the Real-Time Polymerase Chain Reaction (RT-PCR) method is the gold standard for the SARS-CoV-2 infection diagnosis. This method, however, has some limitations where it has a long
turnaround time, complicated operations, and high prices. Hence, the rapid test kits are now readily available to identify the SARS-CoV-2 patients. The purpose of this study is to measure the diagnostic performance, including sensitivity, specificity, positive and negative predictive value, likelihood ratio or LR of antibody rapid test if compared with RT-PCR for the SARS-CoV-2 suspected patients in Bethesda Hospital Yogyakarta. This research was analytical observational research with a cross-sectional design approach, in which data were collected retrospectively. The instruments used in this study included e-medical record (ERM), Laboratory Information System (LIS) data from patients with suspected SARS-CoV-2 infection in Bethesda Hospital Yogyakarta. We collected demographic data of patients, RT-PCR results, antibody rapid test results using Standard Q COVID-19 IgM/IgG Combo. The data were obtained from 50 patients. The results showed that the Rapid test kit has a 100% sensitivity value, 74.4% specificity value, 38.9% positive and 100% negative predictive value, 3906 positive likelihood ratio compared with the RT-PCR results.

Keywords

Rapid antibody test; RT-PCR; SARS-CoV-2

Full Text:

PDF

References

Castro, R., Luz, P.M., Wakimoto, M.D., Velozo, V.G., Grinsztejn, B., Perraxo, H., 2020. COVID- 19: a Meta-Analysis of Diagnostic Test Accuracy of Commercial Assays Registered in Brazil. Brazilian Journal of Infectious Diseases, 24(2), 180-187.

Diagnostic test calculator, 2020. URL https://ebm-tools.knowledgetranslation.net/calculator/diagnostic/ (accessed 12.10.20).

Guo, L., Ren, L., Yang, S., Xiao, M.,Chang,Yang, F., et al., 2020. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. Published online March 28. DOI:10.1101/2020.03.05.20030502.

Joseph, T. (editor in chief), 2020. International Pulmonologist’s Consensus on COVID-19. 2nd edition. [WWW Document]. URL https://www.researchgate.net/publication/340862051_COVID-19-E-Book_International_Pulmonologist's_consensus_on_COVID-19_-_2nd_Edition (Accessed 24.04.20)

Kahfarhood, G., Aghaali, M., Saadati, H.M., Taherpoor, N., Rahimi, S., Izadi, N., & Nazarari, S.S.H., 2020. Epidemiological and Clinical Aspect of COVID-19; A Narrative Rev. Archieves of Academic Emergency Medicine, 8(1), e41.

Kementerian Kesehatan RI, 2020. Gugus Tugas Percepatan Penanganan COVID-19. [WWW Document]. URL https://www.covid19.go.id/ (accessed 18.04.20).

Kementerian Kesehatan RI, 2020. Infografis COVID-19 (24 Oktober 2020). [WWW Document] URL https://covid19.go.id/p/berita/infografis-covid-19-24-oktober-2020 (accessed 24.10.20).

Kemeterian Kesehatan RI, 2020. Pedoman Pencegahan dan Pengendalian Coronavirus Disease (COVID-19). Revisi Kelima.

Li X., Geng M., Peng Y., Meng L., Lu S., 2020. Molecular Immunepathogenesis and Diagnosis of COVID-19. Pharm Anal. Published online March 5. DOI: 10.1016/j.jpha.2020.03.001.

Li Z., Yi Y., Luo X., Xiong N., Liu Y., LiS., et al., 2020. Development and Clinical Application of a Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis. Journal of Medical Virology. DOI:10.1002/jmv.25727.

Long, Q., Deng H., Chen J., Hu J., Liu B.,Liao P., et al., 2020. Antibody responses to SARS-CoV-2 in COVID-19 Patients: The Perspective Application of Serological Tests in Clinical Practice. MedRxiv, 20 March 2020. DOI: 10.1101/2020.03.18.20038018.

Lu, H., Startton, C.W., Tang, Y.W., 2020. Outbreak of Pneumonia of Unknown Etiology in Wuhan, China: The Mystery and the Miracle. Journal of Medical Virology, 92(4).

Pemda DIY, 2020. Laporan Harian COVID-19. [WWW Document]. URL https://corona.jogjaprov.go.id(accessed 24.10.20).

Putra, I.W.G.A.E., Sutarga, I.M., Kardiwinara, M.P., Suariyani, W.L.P., Septarini, N.W., & Subrata, I.M., 2016. Modul Penelitian Uji Diagnosis dan Skrining. Program Studi Kesehatan Masyarakat Fakultas Kedokteran Universitas Udayana.

PDS PatKlin, 2020. Hasil survey Performa RDT Antibodi SARS COV-2. (Power Point Presentation). Perhimpunan Dokter Spesialis Patologi Klinik dan Kedokteran Laboratorium Indonesia.

SD Biosensor. Standard Q COVID-19 IgM IgG Combo. [WWW Document]. URL http://sdbiosensor.com/xe/product/12509 (accessed 20.10.20).

Susilo, A., Rumende CM., Santoso WD., Yulianti M., Herikurniawan., et al., 2020. Coronavirus Disease 2019: Tinjauan Literatur Terkini. Jurnal Penyakit Dalam Indonesia, 7(1), 45-67.

Tim Tanggap Covid-19, 2020. Uji Validasi Tes Cepat antibody ‘Wondfo’ dibandingkan dengan RT-PCR pada pasien terduga COVID-19 di RSUP Dr. Hasan Sadikin, Bandung. JawaBarat.

World Health Organization, 2020. Laboratory Testing for Coronavirus Disease 2019 (COVID-19) in Suspected Human Cases. Geneva: World Health Organization.

World Health Organization, 2020. Coronavirus Disease 2019 (COVID-19) Situation Report–28. [WWW Document] URL Who.int/Indonesia (accessed 24.20.20).

DOI: https://doi.org/10.24071/jpsc.002973