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Go to:. TABLE 1. Open in a separate window. We thank Kittinun Hussem for expert technical assistance. This study was supported by the U. Army Medical Research and Materiel Command. Anderson, D. Li, M. Riddell, T. Howard, H. Seow, J. Torresi, G. Perry, D. Sumarsidi, S. Shrestha, and I. Methods 81 : NIV identifies hepatitis E virus behind jaundice cases.
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High rates of positive results were reached after the first week of clinical illness. Even though the sensitivity was lower during the early stages of the disease, it was greatly improved 8—14 days after symptom onset. AnshLabs showed the highest sensitivity in patients tested within the first two weeks of symptom onset Figure 2. However, AnshLabs had the lowest specificity compared with the other kits.
After 14 days of symptom onset, the sensitivity slightly decreased in all assays, except NovaTec and Lionex. This could be because Hence, these patients might not have elicited enough antibody response to be detected by most of the assays Table S4, group 3 sample Nos.
Typically, if borderline results were obtained in ELISA testing, another sample was taken from the patient 1—2 weeks later for re-testing. However, this was not possible, as sensitivity and specificity were being tested in specific time frames. Considering that these borderline samples were collected from RT-PCR-positive patients, borderline results were considered positive, which was consistent with similar studies Meyer, , Van Elslande, Previous studies performed on other HCoV suggested that the anti-nucleocapsid anti-N antibody response may appear earlier than the anti-spike anti-S response and may wane more rapidly Coste et al.
In the current study, it was expected that the differences in sensitivity between ELISA kits would depend on the targeted protein used in each assay. However, the sensitivity increased in the kit that solely targets the S1 protein Lionex.
Therefore, a possible explanation for this is that the level of anti-N and anti-S antibodies may be similar during the acute phase of COVID illness, but anti-N antibodies could be waning after the second week Coste et al. Moreover, this could also explain the high specificity of Lionex compared with the other assays Figure 1.
That is, Lionex targets the S1 protein, which is smaller and less conserved across different families of viruses than the N protein. Therefore, detection of anti-N antibodies may be useful in distinguishing more recent antibody responses, while anti-S antibody may be used during the early and convalescent phases. However, this does not explain why the sensitivity of NovaTec, which targets the N protein, remained steady after the second week compared with EDI, which also targets the same protein N.
Concordance assessment between the different assays showed good to excellent agreement between the kits. EDI and Dia. Pro had the best overall agreement However, both assays demonstrated the lowest sensitivity in all time points compared with the assays, despite having a very high specificity Therefore, these two assays are the least recommended for diagnosis and clinical relevance.
NovaTec and AnshLabs also showed an excellent positive percent agreement Lionex, however, showed a variation in the agreement with the other ELISA kits, which could be due to the fact that Lionex is the only kit that targets the S1 protein. From an epidemiological perspective, high sensitivity of the assay in combination with robust specificity is desirable.
Both assays showed a diagnostic sensitivity of The specificity of Lionex A strength of this study was the use of a diverse control group to evaluate cross reactivity with antibodies against various viruses, including MERS, SARS-CoV, endemic coronaviruses, respiratory viruses, and other viruses.
One of the limitations of this study was that the clinical details of the patients were unavailable, which are important to understand why some of them did not develop an antibody response detectable by the evaluated kits. It would be very beneficial to perform a new study using a large sample size collected from patients with known disease severity outcomes e. Further, all assays showed acceptable specificity, ranging from Finally, although serological assays do not replace molecular tests in diagnosing active infection, they serve as an essential tool with which to accurately estimate the seroprevalence of SARS-CoV-2 in the general population and to quantify the level of herd immunity Winter and Hegde, This could help ease the restrictions on human mobility and interactions without provoking a significant resurgence of transmission and mortality.
Further studies are essential to distinguish functional antibodies from total binding antibodies using virus neutralization assays. This work was made possible by grant No. The statements made herein are solely the responsibility of the authors. Hadi M. Duaa W. Soha R. Salma N. Younes: Methodology, Validation, Data curation.
Farah Shurrab: Methodology, Validation, Data curation.
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