CONTIPHARMA-COVID19 is the dedicated catalog of CONTIPHARMA (renowed pharmaceutical products distributor since 2016) to help saving lives and overcome the COVID-19 virus.
As long as there is no vaccine against the COVID-19 pandemic, our main goal is to provide high reliability tests and equipments to our health partner worldwide as well as :
- q-PCR, IgG and IgM Tests
- Civil and Medical Masks
- Face shields
- Protection Goggles
- Material (ventilators, thermometers, …)
The q-PCR Coronavirus kit test can accurately detect positive people within 2 hours!
The q-PCR kit test Coronavirus (SARS-CoV-2) CE-IVD Detection Test is an ‘in vitro’ test based on the real time test PCR technology developed against the SARS-CoV-2 viral RNA from nasopharyngeal and oropharyngeal swab and sputum from patients suspected of being infected with the new coronavirus. The analytical sensitivity is 1 copy per reaction (100 copies / ml) of SARS-CoV-2 viral RNA with a confidence level of 95%. The test is very specific without cross-reaction with different types of non-SARS-CoV-2 species tested.
With this test, the general public will know :
- if they are infected with the COVID19 or with the common flu virus, even if the symptoms are similar.
- if they are carrying the COVID19 virus without symptom and risk to infect their loved ones and those who are in contact with them.
- if they are carrying the COVID19 virus and could benefit from the treatment window
TEST PERFORMANCE :
The test has a wide dynamic range : Amplification curve of a 10-fold serial dilution showing the dynamic range.
The summary of test performance for Detection Test :
- Intra-test reproducibility : variation coefficient (%): <3%
- Operator reproducibility : variation coefficient (%): <2%
- Inter-instrument reproducibility : variation coefficient (%): <6%
Test detection limit (LOD) : 1 copy of virus RNA or 100 copies per ml of sample.
KEY INFORMATION :
- Manufactured in South -Korea
- Detects three genes, the Orf1ab, N and E genes
- Detects different strains of SARS-CoV-2 virus
- Detection from a copy of virus RNA
- Less than 2 hours between RNA and results on most q-PCR machines
Those q-PCR and other equipments are manufactured in accordance
with the international certifications :
- DIN EN ISO13485:2016
- EU product Notification IVD 2020-03-27
- EN 15223-1:2016
- EN 13612:2002/AC:2002
- EN 13975:2003
- EN ISO 14971:2012
- EN ISO 17511:2003
- EN ISO 18113-1:2011
- EN ISO 18113-2:2011
- EN ISO 23640:2015