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The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection
Orv Hetil. 2020 05 01; 161(20):807-812.OH

Abstract

Introduction: At the end of March, 2020, rapid tests detecting the presence of antiviral IgM and IgG antibodies against SARS-CoV-2 virus were introduced in Hungary for the identification of SARS-CoV-2 infection (COVID-19 disease).

Aim:

We evaluated two rapid tests (Anhui and Clungene) in comparison with those of real-time PCR tests considered as the gold standard in the detection of infection. Method: Between 16, March and 14, April, 2020, we performed rapid IgM and IgG detecting tests without PCR; PCR without rapid tests; and PCR WITH rapid tests in 4140, 3210 and 1654 patients, respectively. (Out of these 1654 patients, Anhui and Clungene tests were used for testing in 625 and 1029 patients, respectively.) Patients were considered as positive in PCR and rapid tests when PCR positivity and IgM or IgG positivity occurred at any time, respectively. (Note: Clungene test is also marketed as 'Lungene'.)

Results:

The prevalence of PCR positivity in 4864 patients tested with PCR was 6.3%. The sensitivity and specificity of Anhui and Clungene tests were 33.3% and 72.85%, and 35.48% and 85.02%, respectively. At 6% PCR positivity, the positive and negative predictive values of Anhui and Clungene were 7.28%, 94.48%, 13.13%, and 95.38%, respectively.

Conclusion:

The low positive predictive values indicate that Anhui and Clungene rapid tests detecting the presence of anti-IgM and anti-IgG against SARS-CoV-2 virus infection are not suitable for screening SARS-CoV-2 vírus infection in the general population. These results strongly support that Anhui and Clungene rapid tests detecting IgM and IgG antibodies against SARS-CoV-2 virus should not be used in the differential diagnosis of infection. Orv Hetil. 2020; 161(20): 807-812.

Authors+Show Affiliations

Semmelweis Egyetem, Budapest, Nagyvárad tér 4., 1089.Semmelweis Egyetem, Budapest, Nagyvárad tér 4., 1089.Semmelweis Egyetem, Budapest.Semmelweis Egyetem, Budapest.Semmelweis Egyetem, Budapest.Semmelweis Egyetem, Budapest.

Pub Type(s)

Journal Article

Language

hun

PubMed ID

32364358

Citation

Vásárhelyi, Barna, et al. "The Diagnostic Value of Rapid Anti IgM and IgG Detecting Tests in the Identification of Patients With SARS CoV-2 Virus Infection." Orvosi Hetilap, vol. 161, no. 20, 2020, pp. 807-812.
Vásárhelyi B, Kristóf K, Ostorházi E, et al. The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection. Orv Hetil. 2020;161(20):807-812.
Vásárhelyi, B., Kristóf, K., Ostorházi, E., Szabó, D., Prohászka, Z., & Merkely, B. (2020). The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection. Orvosi Hetilap, 161(20), 807-812. https://doi.org/10.1556/650.2020.31859
Vásárhelyi B, et al. The Diagnostic Value of Rapid Anti IgM and IgG Detecting Tests in the Identification of Patients With SARS CoV-2 Virus Infection. Orv Hetil. 2020 05 1;161(20):807-812. PubMed PMID: 32364358.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection AU - Vásárhelyi,Barna, AU - Kristóf,Katalin, AU - Ostorházi,Eszter, AU - Szabó,Dóra, AU - Prohászka,Zoltán, AU - Merkely,Béla, Y1 - 2020/05/01/ PY - 2020/5/5/entrez PY - 2020/5/5/pubmed PY - 2020/5/7/medline KW - COVID-19 pandemia KW - COVID–19-pandémia KW - SARS-CoV-2 novel coronavirus KW - SARS-CoV-2 vírus KW - gyorsteszt KW - rapid tests KW - real-time PCR KW - ’real-time’ PCR SP - 807 EP - 812 JF - Orvosi hetilap JO - Orv Hetil VL - 161 IS - 20 N2 - Introduction: At the end of March, 2020, rapid tests detecting the presence of antiviral IgM and IgG antibodies against SARS-CoV-2 virus were introduced in Hungary for the identification of SARS-CoV-2 infection (COVID-19 disease). Aim: We evaluated two rapid tests (Anhui and Clungene) in comparison with those of real-time PCR tests considered as the gold standard in the detection of infection. Method: Between 16, March and 14, April, 2020, we performed rapid IgM and IgG detecting tests without PCR; PCR without rapid tests; and PCR WITH rapid tests in 4140, 3210 and 1654 patients, respectively. (Out of these 1654 patients, Anhui and Clungene tests were used for testing in 625 and 1029 patients, respectively.) Patients were considered as positive in PCR and rapid tests when PCR positivity and IgM or IgG positivity occurred at any time, respectively. (Note: Clungene test is also marketed as 'Lungene'.) Results: The prevalence of PCR positivity in 4864 patients tested with PCR was 6.3%. The sensitivity and specificity of Anhui and Clungene tests were 33.3% and 72.85%, and 35.48% and 85.02%, respectively. At 6% PCR positivity, the positive and negative predictive values of Anhui and Clungene were 7.28%, 94.48%, 13.13%, and 95.38%, respectively. Conclusion: The low positive predictive values indicate that Anhui and Clungene rapid tests detecting the presence of anti-IgM and anti-IgG against SARS-CoV-2 virus infection are not suitable for screening SARS-CoV-2 vírus infection in the general population. These results strongly support that Anhui and Clungene rapid tests detecting IgM and IgG antibodies against SARS-CoV-2 virus should not be used in the differential diagnosis of infection. Orv Hetil. 2020; 161(20): 807-812. SN - 1788-6120 UR - https://www.unboundmedicine.com/medline/citation/32364358/The_diagnostic_value_of_rapid_anti_IgM_and_IgG_detecting_tests_in_the_identification_of_patients_with_SARS_CoV_2_virus_infection L2 - https://akjournals.com/doi/10.1556/650.2020.31859 DB - PRIME DP - Unbound Medicine ER -