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Back to Journal »Multidisciplinary Healthcare Journal» Volume 14
The diagnostic performance of the SARS-CoV-2 IgM/IgG rapid detection kit in Ethiopia's new coronavirus detection
Author Sisay A, Tesfaye A, Desale A, Ataro I, Woldesenbet Z, Nigusse B, Tayachew A, Kebede A, Desta AF
Published on January 27, 2021, the 2021 volume: 14 pages, pages 171-180
DOI https://doi.org/10.2147/JMDH.S290711
Single anonymous peer review
Editor approved for publication: Dr. Scott Fraser
Abay Sisay,1,2 Abraham Tesfaye,2,3 Adino Desale,4 Israel Ataro,5 Zerihun Woldesenbet,6 Bisrat Nigusse,7 Adamu Tayachew,4,8 Adisu Kebede,4 Adey F Desta1 1 University Department of Microbial Cell and Molecular Biology Department of Natural Science and Computing Science, Addis Ababa University, Addis Ababa, Ethiopia; 2 Department of Medical Laboratory Science, School of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 3 Diagnostics Department, Africa Innovation Center for Drug Development and Therapeutic Trials, CDT-Africa, Addis Ababa, Ethiopia; 4 National Laboratory Capacity Building Agency, Ethiopian Institute of Public Health, EPHI, Addis Ababa, Ethiopia; 5 Health of the Federal Democratic Republic of Ethiopia Ministry of Health Promotion Plan and Primary Health Care Bureau, Addis Ababa, Ethiopia; 6 Medical Laboratory Medicine, Yekatit 12 Hospital, Addis Ababa, Ethiopia; 7 Project Management Unit, Ethiopian Public Health Laboratory Association, Addis, Ethiopia Ababa; 8 National Reference Laboratory for Influenza and Arboviruses, Ethiopian Institute of Public Health, EPHI, Addis Ababa, Ethiopia Communication: Abay Sisay Email [Email Protection] Purpose: Rapid Severe Acute Respiratory System Integration Coronavirus 2 test kits are critical to bridging the diagnostic gap between health facilities and community screening, mainly in resource-limited settings. However, there is no objective evidence to prove their diagnostic performance. Therefore, the study aims to evaluate the diagnostic performance comparison of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia. Method: A cross-sectional study of 200 customers was conducted in Addis Ababa, Ethiopia, between May and July 2020. Using blood samples to evaluate the RT-PCR of respiratory swabs, the performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite and ACON Biotech were evaluated. Use Vassarstats, MedCalc and SPSS 23 version statistical software to calculate the sensitivity, specificity and consistency between each other and RT-PCR. Results: The test kit showed heterogeneous comparative diagnostic performance in terms of its sensitivity and specificity. The sensitivity of kits A, B and C were 61.18% (95% CI: 49.96-71.37%), 74.12% (95% CI: 63.28-82.74%) and 83.53% (95% CI: 73.57-90.38%), respectively. Similarly, the specificities of kits A, B, and C were 96.52% (90.81–98.88%), 94.78% (88.52–97.86%), and 94.78% (88.52–97.86%), respectively. The detection kit is consistent with RT-PCR, and the kappa values of A, B, and C are 0.60 (0.48-0.83), 0.71 (0.65-0.93), and 0.80 (0.76-1.04), respectively. There are significant differences in the diagnostic performance of the three detection kits and PCR, with a p value <0.001 Cochran's Q test. Conclusion: The diagnostic performance of the test kit is promising. It is recommended to combine the diagnosis of COVID-19 with RT-PCR to detect more infected patients. It allows to determine the seroprevalence of the virus and the true extent of SARS-COV-2 community spread in resource-limited environments. We emphasize that countries evaluate rapid diagnostic test kits before diagnostic use. Keywords: COVID-19, diagnostic performance, Ethiopia, rapid test, sensitivity, specificity
Coronavirus disease 2019 (COVID-19) is the current public health pandemic. Since it was first reported in Wuhan, China in late December 2019, as of November 2, 2020, there were 46,834,497 cases worldwide, including 1,205,432 deaths. Has become the biggest threat in recent decades. 1 –3 Since many cases are asymptomatic, laboratory tests are not performed, positive cases cannot be determined, and the source of infection cannot be traced. WHO recommends “testing, testing, and testing” as very important to alleviate and control the pandemic. Means. Therefore, in this case, an affordable and user-friendly 4-laboratory test package should be considered, mainly for more realistic rapid tests in low-income countries, which can be performed by a minimum of trained personnel and resources manage. 5,6 Many rapid diagnostics that can detect SARS-CoV-2 have been and are being developed internally and commercially. 7-9 Although the cost of rapid laboratory test kits is relatively low and simple, their quality is subject to strict scrutiny, which exposes and weakens the health system and forces countries and diagnostic companies to be Availability nearby. 10-12
Africa’s health system and laboratory diagnostic capabilities have problems in detecting outbreaks as early as possible, while the 2,030 Sustainable Development Goal (SDG) has a huge gap in the diagnosis stage. Many people have not been diagnosed, but the problems achieved are 13,14 the same As of October 20, 2020, the number of COVID-19 laboratories in Ethiopia does not exceed 46. As a result, the turnaround time is long, which is not in line with the spread of the virus. 15,16 In addition, the currently recommended “gold standard” test for COVID-19 is based on real-time reverse transcriptase PCR (rRT-PCR). Its sensitivity is limited, the procedure is relatively cumbersome and easy to be contaminated, it also requires the most advanced laboratory equipment, expensive consumables and skilled professionals. 17,18
These challenges have forced scientists to develop accurate, reliable, and rapid diagnostic methods for COVID-19; however, it is necessary to evaluate their performance and introduce high-quality rapid detection kits that can identify, screen, and trace the source of infection To help control the COVID 19 pandemic. Therefore, this study aims to compare and evaluate the diagnostic performance of the selected SARS-CoV-2 IgG/IgM rapid test for the new coronavirus with the RT-PCR currently established in Ethiopia.
A multi-center cross-sectional study was conducted at the Addis Ababa COVID-19 Isolation and Testing Center from May to July 2020: EPHI National Influenza Reference Laboratory, Ekka Kotebe General Hospital, Yekatit 12 Hospital School of Medicine, Asia The Addis Ababa Health Authority Public Health Research and Emergency Management (AAPHREM) Center. These locations were one of the first national COVID-19 testing and treatment centers, and samples came from other referral medical institutions in Addis Ababa. 19-21
Overall, during the study period, 540 customers who ordered sequentially were screened for COVID-19 symptoms. Among them, 200 voluntarily participating clients provided written informed consent and consent to participate, and developed signs and symptoms of COVID-19 during the consultation, such as fever BT ≥ 37.5, cough, sore throat, runny nose, and sneezing 22 were unable to Critically ill patients communicated are not included. Study participants were recruited through trained public health professionals in accordance with current WHO and Ethiopian COVID-19 management guidelines. 22-24
When selecting the rapid test kit included in this evaluation study, affordability, FDA approval or listing emergency use authorization and user-friendliness were considered as the minimum criteria. 25 Among the ten local drug distributors that were communicated, only 3 companies were interested in this and used test kits. evaluate. Accordingly, three SARS-CoV-2 IgG/IgM rapid test kits were selected: EGENE (A), CTK BIOTECKs Onsite (B) and ACON Biotech (C) for performance evaluation to detect the new type of coronavirus against the RT-PCR method Virus. For each rapid test kit, we received 200 samples from these companies through their local representatives in Ethiopia. However, these pharmaceutical companies were not involved in the design, analysis, and writing of research manuscripts. SARS-CoV-2 IgG/IgM Rapid Test is a lateral flow chromatography immunoassay that can detect antibodies against SARS-CoV-2 virus. The test kit includes: a colored conjugate pad containing SARS-CoV-2 recombinant antigen conjugated with colloidal gold (SARS-CoV-2 conjugate) and nitrocellulose containing IgG thread, IgM thread and control thread (C) Plain film strips. 8,28
The sociodemographic characteristics of the participants were captured by using pre-tested data collection tools. According to the national SOP and strict biological safety measures, use virus transfer medium (VTM) and ethylenediaminetetraacetic acid (EDTA) coated vacuum blood collection tubes to collect nasal/throat swabs and blood samples. 16,29 The collected swab specimens were immediately sent to the Molecular Laboratory (EPHI) National Influenza Reference Laboratory and the Addis Ababa Public Health Emergency Management Center Laboratory (AAPHREM) for testing through triple packaging.
Molecular RT-PCR was performed using Applied Biosystems 7500 real-time PCR system and Abbott m2000sp/m2000rt real-time PCR platform. 23,30 RDT uses three IgG/IgM rapid test kits (Nantong Egens Biotechnology EGENE is labeled A, CTK's on-site COVID-19 IgG/IgM rapid test, CTK BIOTECH is labeled B and ACON Biotech SARS-CoV-2 IgG/IgM The rapid test is marked as C) Follow the manufacturer's instructions. The results are explained by two independent readers. 26-28
The PCR results of study participants are communicated through the established National Emergency Operations Center, because the country has a COVID-19 results communication channel to centrally manage cases, while RDT results are exchanged on-site. SARS-CoV-2 IgG/IgM rapid test is a lateral flow chromatography immunoassay that can detect antibodies against SARS-CoV-2 virus. The test kit includes: a colored conjugate pad containing SARS-CoV-2 recombinant antigen conjugated with colloidal gold (SARS-CoV-2 conjugate) and nitrocellulose containing IgG thread, IgM thread and control thread (C) Plain film strip. It was carried out in accordance with the instructions of the respective manufacturers, the results were read at 10 to 20 minutes, and no results were read after 20 minutes. The result is interpreted as that, in addition to the existence of the C line, if only the G line is cultured, the test results indicate the presence of IgG anti-SARS-CoV-2 virus. The result is IgG positive. In addition to the existence of the C line, if only the M line is cultivated, the test indicates the presence of IgM anti-SARS-CoV-2 virus. The result is IgM positive. In addition to the existence of the C line, if the G line and the M line appear at the same time, the test shows the presence of IgG and IgM anti-SARS-CoV-2 virus, and the result is IgG and IgM positive. 8,26-28
Data collectors were trained on how to use data collection tools to collect the necessary data, and they were provided with additional written guidelines explaining each research variable. Molecular laboratories: EPHI National Influenza Reference Laboratory and AAPHRM, the laboratory tests carried out were respectively accredited by WHO and (Ethiopian National Accreditation Office (ENAO) ISO15189:2012. 24,31 RDT contains built-in control functions, C line. Positive and Negative control) was tested to ensure the correct performance of the assay. 7 We use calibrated micropipettes for sample dispensing.
Use SPSS 23 version, Vassarstats and MedCalc statistical software for dual input and analysis of data. The sensitivity and specificity of RDT were calculated, and the performance consistency with RT-PCR was evaluated using Kappa statistics. Cochran's Q test is used to evaluate whether there is a difference in performance between the rapid test kit and RT-PCR. P value <0.05 is considered statistically significant P value <0.05.
In order to conduct this research, the Institutional Review Board IRB (Protocol #029/20/Lab), Eka Kotebe Hospital IRB Agreement #Eka-150-5-4) and Addis Abeba Health’s Ethical Approval Bureau IRB Agreement # A/A/H11127/227. Permission to conduct this research was obtained from the relevant agency: EPHI and the COVID-19 Working Group of the Federal Ministry of Health (they register and allow research work). During the data and sample collection period, the data collector informs each research participant of the purpose and expected benefits of the research project, and informs them that they have the full right to refuse, withdraw or completely refuse to participate in the research, either partially or completely.
Finally, we obtained written informed consent from the parents or legal guardians of adult participants and study participants under the age of 18 to participate in the research and use their files and records for the research. The identifiers of all participants were deleted, and only codes were used to keep secret during the entire research process. In addition, this work was carried out in accordance with the Declaration of Helsinki.
In this study, 200 study participants were included, ranging in age from 1 month to 95 years, with a median of 27±13.75 years. Most of them are men, and 33 people have comorbidities, which may cause the virus to spread, and it is terrible. The detailed information is shown in Table 1. Table 1 Socio-demographic characteristics of study participants, Addis Ababa, Ethiopia in 2020
Table 1 Socio-demographic characteristics of study participants, Addis Ababa, Ethiopia in 2020
Of the specimens in this study, 85 were positive by RT-PCR. The evaluated kits have heterogeneous diagnostic performance, and the sensitivities to A, B, and C are 61.2%, 74.1%, and 83.53%, respectively. The detailed information is shown in Table 2-4. Table 2 Comparison of diagnostic performance of test kit "A" and RT-PCR, 2020, Addis Ababa, Ethiopia Table 3 Comparison of diagnostic performance of test kit "B" and RT-PCR, 2020, Addis, Ethiopia Beba Table 4 Test Kit "C" with RT-PCR, 2020, Addis Ababa, Ethiopia
Table 2 Comparison of diagnostic performance between test kit "A" and RT-PCR, 2020, Addis Ababa, Ethiopia
Table 3 Comparison of diagnostic performance between test kit "B" and RT-PCR, 2020, Addis Ababa, Ethiopia
Table 4 Comparison of diagnostic performance between test kit "C" and RT-PCR, 2020, Addis Ababa, Ethiopia
The diagnostic sensitivity performance of the test kit increases with the date of the patient's clinical symptoms, ranging from 8% CI95%: 1.39-27.50% to 61.68% CI95%: 45.51-75.25%, from 12.19% CI95%: 4.58-27.01% ] To 73.47% CI95%: 57.66–84.60%, from 13.04% CI95%: 5.42–26.95% to 83.87% CI95%: 65.52–95.90% CI 95%: 65.52–95.90% Test kits A, B, and C are available respectively As shown in Table 5, the patients had their first symptoms of clinical COVID-19 from day 0 to more than 15 days, as shown in Table 5. Client, 2020, Addis Ababa, Ethiopia
Table 5 In 2020, Addis Ababa, Ethiopia, the sensitivity performance of the rapid test kit for the date when the client's clinical symptoms appeared
The study showed that the sensitivities of rapid test kits A and B and 83.53% (73.57-90.38%) were 61.18% 95% CI: 49.96-71.37%), 74.12% (63.28-82.74%) and 83.53% (73.57- 90.38%) overall comparative diagnostic performance is C respectively. The consistency of the kappa values of the RT-PCR of the three test kits was 95% CI 0.60 (0.48–0.83), 0.71 (0.65–0.93), 0.80 (0.76–1.04) for A, B, and C. Among the three detection kits and PCR, this study obtained significant differences in the performance of the detection kits with an asymptotic p value <0.001 through Cochran's Q test, as shown in Table 6. Table 6 Overall comparative diagnostic performance of three different commercially available SARS-CoV-2 IgG/IgM rapid detection for RT-PCR, 2020, Addis Ababa, Ethiopia
Table 6 The overall comparative diagnostic performance of three different commercial SARS-CoV-2 IgG/IgM rapid tests on RT-PCR, 2020, Addis Ababa, Ethiopia
The recent ongoing global pandemic has caused serious public health problems. In an unprecedented emergency situation, many companies have developed a large number of diagnostic methods for SARS-CoV-2, including rapid test kits. In view of this, as of August 15, 2020, there are more than 777 SARS-CoV-2 rapid IgG/IgM detection kits on the global market. 25 However, there is no document to prove its diagnostic performance in resource-limited environments such as Ethiopia, however. Therefore, the purpose of this study is to evaluate the comparative diagnostic performance of three commercially available SARS-CoV-2 rapid IgG/IgM tests: EGENS (A), CTk Onsite (B) and ACON Biotech (C) SARS-CoV-2 using human Rapid detection of IgG/IgM on blood samples by RT-PCR of respiratory tract samples.
The evaluated SARS-CoV-2 rapid IgG/IgM test has heterogeneous comparative diagnostic performance, with overall sensitivity of 61.18% (95% CI: 49.96-71.37%), 74.12% (95% CI: 63.28-82.74%) and 83.53 % (95% CI: 73.57–90.38%) and the specificities of test kits A and B were 96.52% (90.81–98.88%), 94.78% (88.52–97.86%) and 94.78% (88.52–97.86%), respectively. This is a low finding that does not meet the respective manufacturers' claims of 96.80%, 88.24%, and 99.1% sensitivity, and the specificity is 100%, 100%, and 98.2% of determinations A, B, and C, respectively. The difference may be due to the number of samples and the fact that the manufacturing company did not implement it in the real life of field work, as we did in different medical institutions. 26-28
The sensitivity performance of test kit A is much lower, while the diagnostic sensitivity performance of test kits B and C is comparable to the study of Nicol et al. (overall sensitivity is 80%) and the study of Porte et al. The sensitivity and specificity are respectively 93.9% (CI95% (86.5–97.4)) and 100% (CI95% (92.1–100)), the Kappa coefficient is 0.9, which is consistent with the Ckappa value of 0.8.32,33
In terms of comparative diagnostic specificity, this study showed that kits A, B, and C were 96.52% (90.81–98.88%), 94.78% (88.52–97.86%) and 94.78% (88.52–97.86%), respectively, in line with Van Elslande A study conducted by et al. showed that the diagnostic specificity of IgG was 96.1%, which was consistent with the results of the study by Jääskeläinen et al., with a specificity of 95.1%. 34,35
The study showed that the positive predictive values of the A, B, and C test kits were 92%, 91%, and 93%, respectively, which is consistent with the study done by Irene Cassaniti et al. The PPV using Viva Diag was 87.5% by Krüttgen et al. The sensitivity of the recorded COVID-19 IgM/IgG test in emergency patients is very poor, and the results are comparable to our current research, with specificity and predictive value, with specificities of 96.2%, 88.7%, 100%, and 100% of the four commercial tests. However, the study only focused on IgG and 75 study sera. In our case, we evaluated IgG/IgM and our sample size was 200.36,37
The field CTK biotechnology test has comparable performance to a study conducted by Pallett et al., with a diagnostic sensitivity of 88.2% (95% CI (81.6-93.1)) from 120 of 136; and a specificity of 94% ( 95% CI (87.46-97.8)). It shows that reputable and almost similar discoveries have been made in different geographic cases. 38
This study is more sensitive than the study by Tollånes et al. 39 This may be because they used fewer study participants than we used. On the contrary, compared with a study conducted by Roche, the diagnostic specificity and sensitivity of 5300 blood samples were 99.81% and 100%, respectively, and the results were lower in comparison performance. The difference may lie in the sample size. They performed a serological test two weeks after confirming a positive PCR result. In our context, we tried to perform the test without knowing that its status was presumptive. On the other hand, the third test kit ACON Biotech SARS-CoV-2 IgG/IgM rapid test showed diagnostic performance comparable to Assure Tech. Ensure that the COVID-19 IgG/IgM rapid test equipment and the Biohit Medical (Hefei) Biohit SARS-CoV-2 IgM/IgG antibody test kit are completed in different locations. 40,41
Seven days after the clinical onset, the sensitivity of the test performance increased with the increase of customers, which was consistent with the findings of different research groups made by Cassanitietal., Xie J. et al., Jeffrey D. Whitman et al., indicating that these test kits But if we use it for customers who mainly complain about COVID-19 in peripheral health institutions, the effect will be better. We obtained relatively good specificity, which is expected in countries with relatively low prevalence. 36,42,43
RT-PCR is the currently established gold standard test for the diagnosis of SARS-COV-2 using respiratory specimens. However, it has limitations related to technical procedures, detection limits, susceptibility to contamination, and negative trends after 10 days of clinical effectiveness. In this research, we have been working to propose alternative test methods that are relatively low cost, easy to perform, and provide results in a short turnaround time. Therefore, the current findings indicate that rapid IgG/IgM SARS-COV-2 point-of-care testing plays a key role in patient screening in resource-scarce countries, where the number of RT-PCR laboratories established is limited, and future research is urged for management The ongoing COVID-19 pandemic. 44 In addition, many low-income countries have very low detection performance per capita. 45 Therefore, the availability of rapid and reliable screening tests with alternative sample sources has been marked as critical 44,45 In addition, this may prompt researchers to conduct further research and provide evidence-based guidance for decision makers. How and when they decide to reopen society; and let project managers develop test algorithms and design discharge protocols. 34,37,44
Readers should consider the following points when inferring our results as limitations. For negative results, we did not collect a second specimen for confirmation. In addition, we have not determined the SARS-COV-2 viral load in nasal/throat swabs and the detection limits that may affect the performance of these rapid test kits.
Although the three commercially available SARS-CoV-2 IgG/IgM test kits evaluated show heterogeneity, these two test kits may be good alternative epidemic screening tools and can be combined with RT-PCR Used to detect more infected customers in countries with limited resources such as Ethiopia. By testing and identifying potential sources of infection, this may help minimize the further spread of this deadly and difficult-to-control virus.
Obtaining respiratory swab specimens from critically ill patients is not easy, and their viral load may be reduced, so their PCR results may not be detectable, resulting in false negatives. Therefore, the rapid test kit may be a good alternative because it is relatively easy to execute in a short turnaround time. Nonetheless, considering that our research results reinforce the demand for available rapid test kits, they should be evaluated before use in specific populations. We also recommend further research on the whole genome sequencing of SARS-CoV-2 in Ethiopian isolates to design and verify more sensitive and specific rapid detection kits.
The entire research process is summarized and depicted in Figure 1. Figure 1 A summary diagram of the entire research process evaluating the diagnostic performance of the SARS-CoV-2 IgM/IgG rapid detection kit in Ethiopia for the detection of new coronaviruses.
Figure 1 Diagram of the whole process of the diagnostic performance evaluation of the Ethiopian new coronavirus SARS-CoV-2 IgM/IgG rapid detection kit.
Some data sets such as the names of presumptive and personalized data used and/or analyzed in the current research are not publicly available to maintain privacy, but can be obtained from the corresponding author under reasonable request. For the rest, all relevant data are in the manuscript without supplementary documents.
We would like to thank the University of Addis Ababa for providing us with the opportunity and funding this research from the limited budget available. We are very grateful to Dr. Tadesse Fetahi and his team in the AAU Research Director’s Office for providing all necessary materials, resources and support letters to the research team. This work was achieved with the strong support and timely assistance of his brave financial team, who owned and cooperated with many financial bureaucracies.
We would like to thank the Department of Medical Laboratory Science, School of Health Sciences, Addis Ababa University; Eka Kotebe General Hospital, Ethiopian Institute of Public Health (EPHI), Addis Ababa Health Department and health agencies for considering the urgency of the pandemic , To grant their respective IRBs and licenses through rapid review and enrichment of research programs.
We would like to express our deepest gratitude and thank Dr. Abebaw Gebeyaw, led by the COVID-19 Research Working Group of the Ministry of Health, for facilitating and speeding the registration of the research plan. We would also like to thank Mr. Addis Ashagrie and his team (from Shicholes, Breez and Epherates trading companies) for providing the necessary test kits, allowing us to simplify the customs clearance process and use them in a timely manner when we fully understand the pandemic. Thank you very much.
We would also like to thank Mrs. Rahel Alemu, Mr. Melese Hailu, Mr. Zemenu Tamir and Mr. Tsehay Achameleh, Dr. Yohaness W/kidane, Mrs. Tegbar Getahun, Dr. Natnael Bekuretsion, Dr. Tsegaye G/yes, Mr. Biadgilign Asrat, Mr. Cheru Degfe Data collectors, medical institution managers, thank them for their unreserved cooperation and promotion of all resources.
Last but not least, we are very pleased and thank all study participants for agreeing to participate in this important research.
At this stage, Addis Ababa University received generous financial and material support from its limited budget (Ref #-PR/5.15/590/12/20). However, the funder did not participate in the design, analysis, and writing of the manuscript research method.
We, the author, declare that we have no conflict of interest in this work.
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