March 2020: Coronavirus Test by PCR
March 2020: Coronavirus Test by PCR
March 2020: Coronavirus Test by PCR
March 2020
Isla Lab Caribbean LLC is a distributor for the Caribbean of a novel PCR test from
Co Diagnostics
SARS-CoV-2 (COVID-19)
The disease was first reported in 31-Dec-2019 by the Chinese government to the
World Health Organization (WHO) after a cluster of pneumonia of unknown cause
was identified in the city of Wuhan, Hubei province, China. The virus was found
genetically similar to SARS-CoV, responsible for the 2002-2003 outbreak of severe
acute respiratory syndrome. Signs and symptoms include fever, fatigue, dry cough,
and shortness of breath. Cases of severe infection can result in pneumonia, acute
respiratory distress syndrome (ARDS), and kidney failure leading to death in some
cases. Based on early evidence, many of those who died had other conditions
such as hypertension, diabetes, or cardiovascular disease that impaired their
immune system.
Person-to person transmission, especially close contact, has been confirmed in
asymptomatic and symptomatic phases of the disease. The degree of transmission
on each phase has not been established yet. The incubation period has shown to
be from 1 to 12.5 days, however, because SARS had a 14 days incubation period,
the CDC and WHO recommends considering a 14 days incubation period where
self-isolation and quarantine is recommended. There have been reported outliers
of 24 days incubation period.
Intended Use
SARS-CoV-2 is the virus that causes COVID-19, a contagious, zoonotic disease
that causes respiratory infection varying from common cold symptoms to severe
pneumonia and occasionally death.
The Logix Smart COVID-19 Test Kit is intended for molecular biology applications
to aid in the qualitative detection of Coronavirus disease 2019 (COVID-19) strain
SARS-CoV-2, in patients that meet the clinical criteria for COVID-19 (e.g. fever,
cough, shortness of breath, travel history to China) in lower respiratory tract
(sputum, bronchoalveolar lavage (BAL), tracheal aspirate), upper respiratory tract
(nasopharyngeal and oropharyngeal fluids, nasal swab) and serum.
This Logix Smart COVID-19 real-time RT-PCR assay is a single step reverse
transcription real-time reaction that can be broken down into 3 stages: sample
preparation, reverse transcription, and the polymerase chain reaction with real-time
monitoring. The assay has an internal positive control (IPC) that also acts as an
extraction control to monitor the extraction, amplification, and detection steps.
This product is for export only and is not for sale in the United States.
Kit Specs
A rapid test for the qualitative detection of IgG and IgM antibodies to 2019- nCoV
in human Fingerstick Whole Blood specimens.
For professional in vitro diagnostic use only.
INTENDED USE
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic
immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV
in human Fingerstick Whole Blood specimen.