Summary of Keypoints: WHO/Erasmus Medical Center (MC) Report

 

  • The study was conducted at Erasmus University Medical Center in Rotterdam, Netherlands and was posted on 4/8/2020

  • Three commercial kits were evaluated against RT-PCR:

    • InTec Product Inc – Rapid SARS-CoV-2 Antibody (IgM/IgG) Test

    • Cellex Inc – Qsars-CoV-2 IgG/IgM Cassette Rapid Test (GICA) of Cellex Inc.

    • Diagnox/Healgen – COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

  • Target Reagents:

    • InTec uses N antigen. 

    • Cellex uses a combination of both N and S antigen. 

    • Diagnox/Healgen does not provide this information because it is proprietary information and we do not want to disclose this information to customers

  • 93 Samples tested from confirmed positive donors, who were hospitalized, and 44 negatives from healthy blood donors.

  • Non-human coronavirus infections tested for specificity:

    • Adenovirus

    • Human Metapneumovirus (HMPV)

    • Influenza A

    • Influenza B

    • Respiratory Syncytial Virus A

    • Respiratory Syncytial Virus B

    • Cytomegalovirus (CMV)

    • Epstein-Barr

    • Mycoplasma

    • Rhinovirus

  • Other human coronavirus [HCoV] strains were also tested for specificity:

    • HCov 229E (alpha coronavirus)

    • HCoV-NL63 (alpha coronavirus)

    • HCoV-OC43 (beta coronavirus)

    • MERS-CoV

 

 

Overall Clinical Sensitivity/Specificity

  • Diagnox/Healgen:    Sensitivity 83.33% and Specificity 100%

  • Cellex Inc:                 Sensitivity 79.49% and Specificity 93.62%

  • 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.