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bKIT™ Virus Finder COVID-19

Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV2) is a strain of coronavirus that causes Coronavirus Disease 2019 (COVID-19), the respiratory illness responsible for the ongoing COVID-19 pandemic. SARS‑CoV‑2 undergoes frequent recombination of the positive-sense single-stranded RNA (+ssRNA) about 30,000 bases long that encodes several proteins among which the spike, envelope, membrane, and nucleocapsid structural proteins.

Epidemiology

As of 1 November 2022, there have been 630,818,181 total confirmed cases of SARS‑CoV‑2 infection in the ongoing pandemic2,3. The total number of deaths attributed to the virus is 6,591,1412,3. There are many thousands of variants of SARS-CoV-2, which can be grouped into the much larger clades. The World Health Organization has currently declared five variants of concern (VoC), which are Alpha, Beta, Gamma, Delta and Omicron.

Transmission and symptoms

Transmission occurs via respiratory droplets from coughs and sneezes within a range of about 1.8 meters, but also through speaking, indoors, with little air flow. Indirect contact via contaminated surfaces is another possible cause of infection. Most common symptoms are fever, cough, tiredness, loss of taste or smell, sore throat and headache. In worst cases there can be difficulty breathing or shortness of breath, loss of speech or mobility, or confusion and chest pain leading to hospitalization and possibly death.

The HYRIS bKIT™ Virus Finder COVID-19 is a real-time RT-PCR assay intended to be used as near-patient testing on the HYRIS bCUBE™ instrument and HYRIS bAPP™ for the in-vitro diagnostic qualitative detection of SARS-CoV-2 nucleic acid in human upper respiratory tract specimens such as, nasopharyngeal swabs (NPS) , nasal swabs (NS), and a combination of oropharyngeal swabs (OPS) and NPS , and oropharyngeal and NS specimens collected by a healthcare professional from individuals suspected of COVID-19 disease. The assay is intended for the detection of SARS-CoV-2 RNA, which is generally present in detectable quantity in upper respiratory specimens during the acute phase of the disease.

PRODUCT COMPOSITION

bKTH-SCV2.02-32
Direct Real Time PCR test for SARS-CoV-2 detection in NPS specimens - 32 tests/kit
bKTH-SCV2.02-72
Direct Real Time PCR test for SARS-CoV-2 detection in NPS specimens - 72 tests/kit

RESOURCES

Product datasheet
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Hyris COVID solutions
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FAQ

On which instruments is the assay validated?
bKIT™ Virus Finder COVID-19 is Intended to be used on Hyris System™, composed by the HYRIS bCUBE™ instrument and HYRIS bAPP™ software.
How many samples can be analysed for each run?
Hyris System™ can process 6 or 16 samples per run, depending on the cartridge format to be used.