Diagnosis Performance
91.67%
COVID-19 Sensitivity
(Nasopharyngeal Sample)
100%
COVID-19 Specificity
(Nasopharyngeal Sample)
90%
COVID-19 Sensitivity
(Nasal Sample)
100%
COVID-19 Specificity
(Nasal Sample)
COVID-19 rapid antigen test in human nasal and nasopharyngeal samples
This test is designed to detect the presence of virus proteins. Thus, solving a shortcoming in rapid diagnosis in the early stages of infection that occurred with serological tests for IgG and IgM antibodies, which have a similar detection window to that of PCR tests.
It is available to all segments of the population thanks to a variety of less invasive sampling methods.
Biojam Holding Group’s Rapid Antigen Tests prove effective in diagnosing new strains of COVID-19
Studies carried out by Biojam Holding Group’s antigen test developer have shown that the mutation found in the viral nucleoprotein of SARS-CoV-2 does not interfere with the diagnostic ability of the COVID-19 rapid antigen tests. The guarantee comes after tests demonstrate that the newly identified strains continue to display mutations in the spike protein (S protein) that may be responsible for the increased transmissibility. Our COVID-19 rapid antigen tests do not use S protein in the detection of the virus, but rather the nucleocapsid protein (N protein) which, according to OMS and ECDC information, has not changed.
Advantages
Fast and simple process
Results in 15 minutes
Affordable
Early identification of active and potentially contagious cases
Test procedure after swab sampling
Interpreting test results
PCL COVID-19 Ag Gold – Box contents
25 or 50
Test cassettes PCL COVID-19 Ag Gold
25 or 50
Extraction buffer tubes (500 μL buffer)
25 or 50
Dropper caps with filter
25 or 50
Swabs
1
Information leaflet
Watch how the Ag COVID-19 rapid tests work using saliva samples.
INFARMED IP registration
PCL COVID-19 Ag Gold Rapid Test
Registered in Infarmed (SIDM) on the 28/12/2020 with the CDM 62971956 and CNP 7096990
Brochura Teste Rápido Antigénio – PDF
Download
Instruções de Utilização – PDF
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Cruz Vermelha Alemã
Comparative Study of 3 SARS Antigen Rapid Tests
On November 30, 2020, the developer of the COVID-19 antigen rapid test on human saliva samples (PCL, Inc.) and the company GFE, announced their partnership to promote the PCL COVI19 Ag Gold Saliva test in Germany.
(https://www.gfeblut.de/2020/11/30/pcl-and-gfe-cooperate-on-supply-of-superior-antigen-sars-cov-2-rapid-test/)
GFE is a subsidiary of 3 German Red Cross organizations (DRK Blutspendedienst West, DRK Blutspendedienst NSTOB and Bayerisches Rotes Kreuz).
Abstract:
The DRK-Blutspendedienst Baden-Württemberg | Hessen gemeinnützigeGmbH has completed a study comparing the analytical sensitivity and diagnostic specificity of three rapid antigen tests (Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test | Abbott PanbioTM COVID-19 Ag Rapid Test Device | PCL COVID-19 Ag Gold).
Analytical sensitivity was assessed by performing dilution series of SARS Standard, quantified with GFE SARS-CoV-2 PCR Kit at a PCR Threshold Cycle (Ct) Ct 18 – Ct 22. Triplicate determination of each dilution level was carried out in each rapid test.
Diagnostic specificity was assessed using 200 samples of negative results previously analyzed with GFE SARS-CoV-2 PCR in each of the 3 rapid tests.
Diagnostic sensitivity was assessed using three series of 200 samples out of routine testing, which were initially tested in a rapid test and subsequently in GFE SARS-CoV-2 PCR. Over 2 time periods (June to September 2020 and September to December 2020) a reassessment of COVID-19 routine diagnostic samples was performed. In the first period 1083 samples were tested and 552 samples in the second period.
Results:
Analytical sensitivity
Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test -> Ct 21
Abbott PanbioTM COVID-19 Ag Rapid Test Device -> Ct 21
PCL COVID-19 Ag Gold -> Ct 22
Diagnostic specificity
Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test -> 98.5%
Abbott PanbioTM COVID-19 Ag Rapid Test Device -> 99.5%
PCL COVID-19 Ag Gold -> 100%
Diagnostic sensitivity
First period (June to September 2020)
Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test -> Estimated sensitivity 19.4%
Abbott PanbioTM COVID-19 Ag Rapid Test Device -> Estimated Sensitivity 19.4%
PCL COVID-19 Ag Gold -> Estimated sensitivity 24.3% (or higher) [1] [1] The dilution series used to determine the analytical sensitivity does not include the endpoint for the PCL COVID-19 Ag Gold rapid test. Therefore, the Ct value corresponding to the highest dilution level (level 8, Ct 22) was used for the reassessment.
Second period (September to December 2020)
Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test -> Estimated sensitivity 52.4%
Abbott PanbioTM COVID-19 Ag Rapid Test Device -> Estimated Sensitivity 52.4%
PCL COVID-19 Ag Gold -> Estimated sensitivity 56.2% (or higher) [1] [1] The dilution series used to determine the analytical sensitivity does not include the endpoint for the PCL COVID-19 Ag Gold rapid test. Therefore, the Ct value corresponding to the highest dilution level (level 8, Ct 22) was used for the reassessment.
Click here for the detailed results of the study.
Conclusion:
> Analytical sensitivity of PCL COVID-19 Ag Gold rapid test is superior to that of Roche SD BIOSENSOR SARS-CoV-2 Rapid Antigen Test and of Abbott PanbioTM COVID-19 Ag Rapid Test Device.
> Diagnostic Sensitivity is comparable in all three studies and 200 routine samples.
> The number of positive samples tested correlates with the incidence of cases.
The three rapid tests were found to be very suitable for settings with symptomatic individuals.
A research study carried out by:
Professor Dr. M. Schmidt and Professor Dr. E. Seifried
DRK-Blutspendedienst Baden-Württemberg | Hessen gemeinnützigeGmbH
