Summary of Keypoints: WHO/Erasmus Medical Center (MC) Report
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The study was conducted at Erasmus University Medical Center in Rotterdam, Netherlands and was posted on 4/8/2020
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Three commercial kits were evaluated against RT-PCR:
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InTec Product Inc – Rapid SARS-CoV-2 Antibody (IgM/IgG) Test
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Cellex Inc – Qsars-CoV-2 IgG/IgM Cassette Rapid Test (GICA) of Cellex Inc.
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Diagnox/Healgen – COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
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Target Reagents:
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InTec uses N antigen.
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Cellex uses a combination of both N and S antigen.
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Diagnox/Healgen does not provide this information because it is proprietary information and we do not want to disclose this information to customers
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93 Samples tested from confirmed positive donors, who were hospitalized, and 44 negatives from healthy blood donors.
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Non-human coronavirus infections tested for specificity:
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Adenovirus
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Human Metapneumovirus (HMPV)
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Influenza A
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Influenza B
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Respiratory Syncytial Virus A
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Respiratory Syncytial Virus B
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Cytomegalovirus (CMV)
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Epstein-Barr
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Mycoplasma
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Rhinovirus
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Other human coronavirus [HCoV] strains were also tested for specificity:
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HCov 229E (alpha coronavirus)
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HCoV-NL63 (alpha coronavirus)
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HCoV-OC43 (beta coronavirus)
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MERS-CoV
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Overall Clinical Sensitivity/Specificity
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Diagnox/Healgen: Sensitivity 83.33% and Specificity 100%
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Cellex Inc: Sensitivity 79.49% and Specificity 93.62%
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InTec: Sensitivity 90.29% and Specificity 79.01%
Sensitivity: Probability the test will be positive when the disease is present.
Specificity: Probability will be negative when the target disease is not present.
Conclusion
The Diagnox-Healgen COVID-19 Rapid Test performed better than Cellex which has been granted FDA Emergency Use Authorization (EUA). Diagnox-Healgen’s product was the only test with 100% specificity and demonstrates no cross-reactivity with the listed human coronavirus strains.