Logix Smart™ Coronavirus 2019 (COVID-19) 250 Test Kits (EUA FDA Approved)

Logix Smart™ Coronavirus 2019 (COVID-19) 250 Test Kits

The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses our patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19).

The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract specimens (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract specimens (e.g. nasopharyngeal fluids, nasal swab), and serum from patients who meet the clinical criteria (e.g. signs and symptoms) for coronavirus disease 2019 (COVID-19) as established by WHO (WHO, 2020) and the US CDC (CDC, 2020) (e.g. fever, cough, shortness of breath, travel history to China).

• • Ready-to-use Master Mix, complete with RNaseP internal positive control to verify sample quality
  • Positive Control (PC), to verify the performance of the master mix
  • Nuclease-Free Water as a negative control, to verify master mix is free from contamination

Each kit provides reagents sufficient for 250 reactions.

For Use under the Emergency use Authorization (EUA) only for in vitro Diagnostic use.

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.

Regulatory Clearance

In February 2020, the Logix Smart COVID-19 Test kit received CE marking approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of COVID-19 in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.

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.

Kit Specs