key: cord-0902716-n8di9i8n
authors: Ige, O.; Ayuba Buru, S.; Tanko, Z. L.; Mohammed, T.; Dogara, L.; Ijei, I. P.; Bello-Manga, H.; Audu, R.; Ige, S.; Nmadu, G.
title: Evaluation of SARS-CoV2 antibody Rapid Diagnostic Test kits (RDTs) and Real Time-Polymerase Chain Reaction (Rt-PCR) for COVID-19 Diagnosis in Kaduna, Nigeria
date: 2020-11-27
journal: nan
DOI: 10.1101/2020.11.24.20231324
sha: 23c01bc62069861fe46c7114b6268213b87832f8
doc_id: 902716
cord_uid: n8di9i8n

The emergence of the RNA virus SARS-CoV2, the causative agent of COVID-19 and its declaration by the World Health Organization (WHO) as a pandemic has disrupted the delicate balance in health indices globally. Its attendant immune dysregulation and pathobiology is still evolving. Currently, real time PCR is the gold standard diagnostic test, however there are several invalidated antibody-based tests available for possible community screening. With ongoing community transmission in Nigeria, neither the true burden of COVID-19 nor the performance of these kits is presently known. This study therefore, compared the performance of the SARS CoV2 antibody test and the real time Polymerase Chain Reaction (Rt-PCR) in the diagnosis of COVID-19. For the purpose of this evaluation, we used the diagnostic test kit by Innovita(R) Biological Technology CO., LTD China, a total of 521 venous blood samples were collected from consenting patients for the SARS COVID-19 rapid diagnostic kit and Oral and Nasopharyngeal swabs were collected and analyzed using the real time Polymerase chain reaction technique for nucleic acid detection and quantification.

The SARS-CoV-2 virus is highly contagious and spreads easily within populations. Factors Since onset of this pandemic, schools and a lot of other social activities have come to a 56 standstill. The big question is how long will this remain? Strategies towards gradual 57 reopening of the society have to be developed. Testing for antibodies to the SARS-CoV-58 2 virus and determining the level of herd immunity is a viable strategy that will aid policy 59 makers on deciding when to re-open societies. Despite the medical, social and economic 60 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. However, the WHO recommends the validation of these test kits in appropriate 79 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint populations and settings. (WHO, 2020) This is to prevent false positive or negative 80 categorization of people which may hinder disease control efforts.

The availability of a locally validated and adapted antibody test kit will improve the ease 82 and access to a screening tool for point of care testing in primary, secondary and tertiary 83 health care centres thereby, strengthening the local testing capacity for COVID-19. This 84 will generally improve the ease of diagnosis/screening of COVID-19 in resource 85 constrained settings. The detection of asymptomatic infections using a locally validated 86 serological test kit will also improve community surveillance capacity, which will aid in 87 decision making on measures to control the viral spread such as when to enforce 88 quarantine or isolation.

The ability to detect the immune response using a rapid and reliable serology test has a immunity, in the absence of specific drug therapies or vaccines. The screening can also 99 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint Page 6 of 24 help measure and determine how the society gradually ease back to normalcy and the The study was conducted at 3 sites using both experimental and cross-sectional study 108 designs. We employed an experimental study design as described by Momeni et al For the purpose of this evaluation, the diagnostic test kit by Innovita® Biological 115 Technology CO., LTD China, will be used on Venous whole blood samples (4.0mls) 116 dispensed into Ethylene diamine tetra-acetic acid (EDTA) anticoagulated bottles.

117 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint Oral and Nasopharyngeal swabs will be analyzed using the real time Polymerase chain 118 reaction technique for nucleic acid detection and quantification, following RNA extraction 119 (with Liferiver extraction kits, Shanghai, China) using primers obtained from Genefinders 120 Company LTD, South Korea. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint Page 8 of 24

Data was analyzed using SPSS data analysis package ver. 23. Data for validation studies is 134 presented as percentages. Qualitative daft is summarized as percentages using charts 135 and tables. Non skewed quantitative data will be summarized as means and standard 136 deviations (SD) while skewed data will be summarized as medians and interquartile 137 ranges (IQR). Proportions will be compared using Z-tests for proportions. Level of 138 statistical significance will be set at p≤0.05. Table 1 : Sociodemographic characteristics of participants N=521 153 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (Tables 2 and 3) . preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. There was a statistically significant difference found between sociodemographic 204 characteristics sex (P=0.015) and IgG status of cases. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint in this study were not very high, indicating that this rapid test would not be useful for 249 detecting past infections and possible immunity. It is not known when infection occurred 250 for individuals in this study. The timing of the development of SARS-CoV-2-specific 251 antibodies is variable. The humoral response kinetics to SARS-CoV-2 infection have not 252 been fully understood, however it has been shown that reactive IgA, IgM, and IgG 253 antibodies have been detected as soon as 1 day after symptom onset (Guo, 2020) . In 254 other previous studies, the antibodies were detected 10 to 15 days after symptom onset.

The median time to the development of total antibody, IgM, and IgG has been estimated 256 as 11, 12, and 14 days, respectively (Zhao,2020; Wu F,2020) . We also investigated the any difference between males and females. However, the average IgG antibody level in 268 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint female patients tended to be higher than that of in male patients in severe infections. It for the approval of this pilot study, Barau Dikko Teaching Hospital (BDTH) and the 287 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint

Changes in human nasal mucosa during 330 experimental coronavirus common colds

Serological diagnostic kit of SARS-CoV-2 antibodies using 332 CHO-expressed full-length SARS-CoV-2 S1 proteins

Profiling early humoral response to diagnose novel 334 coronavirus disease (COVID-19)

Antibody responses to SARS-CoV-2 in patients of novel 337 coronavirus disease 2019

Neutralizing antibody responses to SARS-CoV-2 in a COVID-340 19 recovered patient cohort and their implications. medRxiv. Preprint posted online

Seroprevalence of antibodies against SARS

CoV-2 among health care workers in a large Spanish reference hospital

All rights reserved. No reuse allowed without permission

preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this this version posted

preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this this version posted November 27, 2020. that attempt to identify if one has been previously infected by identifying special proteins 366 All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The findings from this study will hopefully make COVID-19 testing cheaper and less preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint Page 23 of 24The full procedure for the tests has been explained to me and I understand that my 387 blood sample and oral/nasal swab will be taken.

I make this consent without being subjected to any pressure. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this this version posted November 27, 2020. ; https://doi.org/10.1101/2020.11.24.20231324 doi: medRxiv preprint