Table 1.
Analytical performances of 5 rapid diagnostic tests for IgG and IgM to SARS-CoV-2.
| BIOSYNEX COVID-19 BSS (IgG/IgM) |
Humasis COVID-19 IgG/IgM Test |
LYHER COVID-19 IgM/IgG Rapid Test |
SIENNA (IgG/IgM) | NG-BIOTECH COVID-19 (IgG/IgM) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Results | TP | FP | TN | FN | Results | TP | FP | TN | FN | Results | TP | FP | TN | FN | Results | TP | FP | TN | FN | Results | TP | FP | TN | FN |
| N = 100 | 46 | 1 | 51 | 2 | N = 100 | 44 | 7 | 45 | 4 | N = 50a | 24 | 0 | 24 | 2 | N = 100 | 47 | 1 | 51 | 1 | N = 99a | 43 | 8 | 44 | 4 |
| Sensitivity IgG/IgM | 95.8 % | [90.2−100.0%]* | Sensitivity IgG/IgM | 91.6 % | [83.8−99.5%] | Sensitivity IgG/IgM | 92.3 % | [82.1−100.0%] | Sensitivity IgG/IgM | 97.9 % | [97.9−100.0%] | Sensitivity IgG/IgM | 91.4 % | [83.5−99.5%] | ||||||||||
|
Specificity IgG/IgM |
98.1 % | [94.3 %–100.0 %]* |
Specificity IgG/IgM |
86.5 % | [77.3−95.8%] |
Specificity IgG/IgM |
100.0 % | [79.6−100.0%] |
Specificity IgG/IgM |
98.1 % | [87.9 %–100.0 %] |
Specificity IgG/IgM |
84.6 % | [74.8−94.4%] | ||||||||||
| Agreement§ | 97 % | Excellent | Agreement | 89 % | Good | Agreement | 96 % | Excellent | Agreement | 98 % | Excellent | Agreement | 87 % | Good | ||||||||||
| Concordance$ | 0.94 | Almost perfect | Concordance | 0.78 | Substantial | Concordance | 0.92 |
Almost perfect |
Concordance | 0.95 | Almost perfect | Concordance | 0.75 | Substantial | ||||||||||
| Accuracy£ | 93.9 % | Excellent | Accuracy | 78.1 % | Acceptable | Accuracy | 92.3 % | Excellent | Accuracy | 96.0 % | Excellent | Accuracy | 76.0 % | Acceptable | ||||||||||
|
HAS criteriaμ |
Yes | HAS criteria | No |
HAS criteria |
Yes |
HAS criteria |
Yes |
HAS criteria |
No | |||||||||||||||
FN: False negative; FP: False positive; HAS: Haute Autorité de Santé (High Authority of Health); T: Total; TN: True negative; TP: True positive; WHO: World Health Organization.
The availability of the LYHER COVID-19 IgM/IgG Rapid Test was limited and 1 out of 2 sera were randomly selected to be tested by this test; the NG-BIOTECH COVID-19 (IgG/IgM) was tested with only 47 sera of group 1, because the quantity of 1 serum of this group was insufficient.
95 % confidence intervals in brackets were calculated using the Wilson score bounds.
Agreement = TP + TN / TP + FP + TN + FN; agreement in expressed in percentage.
The Cohen’s κ coefficient calculation was used to estimate the concordance (Cohen, 1960) and interpreted according the Landis and Koch scale (Landis & Koch, 1977) as follows: < 0 as indicating no agreement, 0–0.20 as slight, 0.21–0.40 as fair, 0.41–0.60 as moderate, 0.61–0.80 as substantial, and 0.81–1 as almost perfect agreement.
Accuracy was estimated by Youden’s J index = sensitivity + specificity – 1; accuracy is expressed in percentage.
HAS criteria: According to the specifications defining the methods for evaluating the performance of serological tests detecting the antibodies directed against SARS-CoV-2 of April 16, 2020 by the so-called Haute Autorité de Santé (HAS, Saint-Denis, France; https://www.has-sante.fr/upload/docs/application/pdf/2020-04/cahier_des_charges_test_serologique_covid19.pdf), the minimum clinical sensitivity of a serological test must be 90 % (or even 95 %) and its minimum specificity 98 %.