MEDICOVID SARS-CoV2 Schnelltest mit Schweizer Ergebnissen, BAG Listung
Medicovid-AG® SARS-CoV-2 Antigen Schnelltest
Der Antigen Schnelltest Medicovid dient dem qualitativen Nachweis einer akuten SARS-CoV-2-Infektion. Der Test identifiziert das für SARS-CoV-2 spezifische Antigen in Proben aus dem Nasenrachenraum und liefert innerhalb von15 Minuten ein Ergebnis mit 99,5% Genauigkeit: 99,9% Spezifität, Sensitivität 96,5% und 97,50% (bei Infektion <4 Tage bzw. PCR cycle time 26), in klinischen Studien validiert (Studie 1 mit 236, Studie 2 mit 471 und Schweizer Studie vom BAG mit 300 Proben), CE-zertifiziert. Gelistet beim BfArM und beim Schweizerischem BAG nach neutraler Validierung im Vergleich zu PCR und mit besseren Ergebnissen als der Schnelltest von Roche. In Packungsgrößen von 1, 20 und 25 Tests pro Packung erhältlich.
Aufgrund der kurzen sample-to-answer Zeit und der hohen Testfrequenz können Infektionsketten rasch unterbunden und ein Ausbruch der Infektion kontrolliert werden.
Schneller Nachweis einer akuten SARS-CoV-2 Infektion (in der ersten Woche der Infektion)
binnen 15 Minuten am Point-of-Care
sehr hohe Genauigkeit, identisch zu PCR mit einer cycle time von >26
Infizierte schnell erkennen und frühzeitig Infektionsketten unterbrechen
PCR-Test-Kapazitäten sinnvoll entlasten.
Dr. Selina Schwegler, Federal Office of Public Health
Email: selina.schwegler@admin.bag.ch
cc: validation@swissmicrobiology.ch
22. December 2020
Technical validation report Rapid COVID-19 Antigen test
Assay name: MediCovid Ag Test
Assay Lot number: 20111302
Company: Xiamen Boson Biotech Co., Ltd
Distributor: Salmon-pharma; René Marksitzer (R.Marksitzer@salmon-pharma.com)
Summary
The MediCovid Ag Test has passed the validation criteria as described by the Swiss Society
of Microbiology. At Ct-values of 23, 26 and 29, the MediCovid Ag Test assay showed a
technical sensitivity of 100%, 97.1% and 90% compared to a reference standard showing a
technical sensitivity of 98%, 92.8% and 85%, respectively. The technical specificity was
99.5%.
Interpretation of technical sensitivity and specificity
Technical sensitivities at Ct 23, 26 and 29, as well as the overall specificity is shown in Table
1. Figure 1 shows the percentage of antigen positivity in relation to Ct values over a range of
100 PCR-positive clinical samples. In order to detect 90% and 80% of PCR positive samples,
the MediCovid Ag Test required a minimum Ct 29.1 and 32.3, respectively, in contrast the
reference standard requires a minimum Ct of 26.40 and 31.1.
Sensitivity
Specificity
Ct 23
Ct 26
Ct 29
Reference
98%
92.8%
85%
99.5%
MediCovid
100%
97.1%
90%
99.5%
Table 1. Technical sensitivity and specificity, expressed in percentage. For sensitivities at Ct 23, 26 and 29 a
threshold of 95%, 90% and 80% has to be reached. Overall specificity needed to be at least 99%
Figure 1. Percentage of antigen positivity compared to Ct values of samples.
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The median Ct values in antigen positive samples were 21.64 for the MediCovid Ag Test
assay and 21.48 for the reference standard (Figure 2).
Figure 2. Ct values of SARS-CoV-2 specific rapid antigen positive and negative tested samples from routine
diagnostics. Boxes show median and interquartile range, whiskers show 10-90th percentile.
Samples tested from serial dilution
The serial dilution from positive samples indicates that the MediCovid Ag Test assay had a
1-titer higher sensitivity. The minimal positivity of 23.3 and 23.1 has been reached.
Ct
21.1
21.9
23.3
24.4
25.1
26.1
27.7
Cell culture MediCovid
+
+
(+)
(+)
-
-
-
supernatant
Reference
+
+
+
+
(+)
-
-
Ct
21.4
22.3
23.1
24.1
25.5
26.4
27.3
Clinical
MediCovid
+
+
+
+
(+)
-
-
sample
Reference
+
+
+
(+)
-
-
-
Table 2. Serial dilution of 2 highly positive sample in a back-to-back comparison. +, clear positive reaction, (+) faint
band, and – negative. Green shade indicates the range within a test has to be positive.
Methods
The technical performance was validated in (i) 100 PCR-positive and 200 PCR-negative
samples and (i ) in a serial dilution against a reference standard in order to determine and
compare the diagnostic limits of detection.
In general samples were used from the routine diagnostic of the validating laboratory. To allow
for a cross-laboratory comparison, 5 SARS-CoV-2 PCR-positive samples were used from
aliquoted samples of one single laboratory and distributed to all laboratories. In addition, 50
SARS-CoV-2 PCR negative samples with other respiratory viruses were used and tested by
all laboratories. These samples included the fol owing viruses: Coronaviruses (229, HKU1,
OC43, NL63, n=3 each), Parainfluenza 1-4 (n=3 each), Rhino/Enteroviruses (n=5 each),
Influenza A and B (n=6 each), RSV (n=6 each), and human Metapneumovirus (n=3).
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Reference standard: Standard Q COVID-19 Rapid Antigen Test from SD Biosensor/Roche
Reference Lot number: QCO3020105
PCR System: Cobas 6800, Roche, E-Gene was considered for Ct-values
Minimal acceptance criteria to successfully pass the validation:
- Cumulative sensitivity at Ct 23 (approx. 10’000’000 c/mL), at least 95%
- Cumulative sensitivity at Ct 26 (approx. 1’000’000 c/mL), at least 90%
- Cumulative sensitivity at Ct 29 (approx. 100’000 c/mL), at least 80%
- Overal specificity, at least 99%
- Serial dilution has to detect up to Ct 23.3 and 23.1, respectively.
This validation report was released for the FOPH
In behalf of the Swiss Society of Microbiology
Members of the core validation team:
- Prof. Adrian Egli, Clinical Bacteriology and Mycology, University Hospital Basel
- Dr. Hans Fankhauser, Clinical Microbiology, Cantonal Hospital of Aarau
- Prof. Gilbert Greub, Clinical Microbiology, University Hospital Lausanne
- Prof. Hans H. Hirsch, Clinical Virology, University Hospital Basel
- Reto Lienhard, ADMed Microbiologie, La Chaux-de-Fonds
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