LOGIX SMART™ COVID-19 TEST
Logix Smart™ Coronavirus 2019 (COVID-19) Test Kit
US FDA-EUA
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 fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) 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).
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Ready-to-use Master Mix, complete with RNaseP internal positive control to verify sample quality
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Positive Control (PC), to verify the performance of the master mix
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Nuclease-Free Water as a negative control, to verify master mix is free from contamination
Schedule online. It's easy, fast and secure.
Safeguard DNA Diagnostics Inc. & Co-Diagnostics Inc.
In line with Safeguard DNA Diagnostics Inc’s commitment to provide quality, fast, accurate and affordable tests in the Philippines. SDDI partnered with Co-Diagnostics, Inc., a molecular diagnostics company, based in Utah, manufacturer of high quality and US FDA certified test kit - Logix Smart COVID-19 test kit. Each kit provides reagents sufficient for 100 reactions.
Logix Smart COVID-19 test kit was granted Emergency Use Authorization (EUA) by the US FDA for use in detecting the deadly virus. The test has already shown 100% sensitivity and 100% specificity in identifying SARS-CoV-2 without showing any cross-reactivity with other coronaviruses. The test is easy to use as well as interpret.
Logix Smart COVID-19 test kit was registered in the Philippine FDA by Safeguard DNA Diagnostics Inc in April 6, 2020.
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.