Case Study: Product Comparison ErasmusMC, Viroscience (WHO Funded)

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Published on Apr 8th, 2020

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Clinical sensitivity and specificity of three rapid SARS-CoV-2 Antibody (IgM/IgG) Tests on a hospitalized patient cohort: InTec, Cellex and OrientGene (test offered by Confirm BioSciences)

Conclusion

According to the test results of the 93 samples from PCR confirmed COVID-19 patients, the sensitivity/specificity of the tests are:

• InTec Rapid SARS-CoV-2 Antibody (IgM/IgG) Test has an overall sensitivity of 90.29% (95% CI: 82.87% to 95.25%) and specificity of 79.01% (68.54% to 87.27%). The sensitivity on samples collected after 7 days from the symptom on set is 94.67% (95%CI:86.90% to 98.53%), specificity is 79.01% (68.54% to 87.27%).

• Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test (GICA) has an overall sensitivity of 79.49% (95%CI:71.03% to 86.39%) and specificity of 93.62% (82.46% to 98.66%). The sensitivity on samples collected after 7 days from the symptom on set is 88.75% (95%CI:79.72-94.72%), specificity is 93.62% (82.46% to 98.66%).

Orient Gene/Healgen COVID-19 IgG/IgM Rapid Test Cassette has an overall sensitivity of 83.33% (74.94% to 89.81%) and specificity of 100.00% (66.37%-100%). The sensitivity on samples collected after 7 days from the symptom on set is 88.46% (79.22% to 94.59%), specificity is 100% (66.37%-100.00%).

Compared to RT-PCR, InTec product showed the highest overall sensitivity followed by OrientGene and Cellex. Samples >7 days post symptom onset were detected more often.

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