OUR COVID-19 TEST KIT
Logix Smart™ Coronavirus 2019 (COVID-19) Test Kit
US FDA-EUA
The Logix Smart Coronavirus Disease 2019 (COVID-19) kit is an in vitro diagnostic test, based on real-time PCR (qPCR) technology, for the qualitative detection of the ribonucleic acid (RNA) from SARS-CoV-2 (COVID-19) in lower respiratory specimen (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract (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 the WHO (WHO, 2020) and the US CDC (CDC, 2020) (e.g. fever, cough, shortness of breath, travel history to endemic areas).
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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.
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 Coronavirus Disease 2019 (COVID-19) test is a real-time RT-PCR test using a proprietary technology called CoPrimers™ (Satterfield, 2014)(Poritz & Ririe, 2014) intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from individuals with signs and symptoms of infection who are suspected of having COVID-19. The test is available to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Logix Smart Coronavirus Disease 2019 (COVID-19) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Logix Smart Coronavirus Disease 2019 (COVID-19) test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
References for the above citations:
Poritz, M., & Ririe, K. (2014, Mar). Getting things backwards to prevent primer dimers. Journal of Molecular Diagnosis, 159-62. doi:10.1016/j.jmoldx.2014.01.001
Satterfield, B. (2014, Mar). Cooperative primers: 2.5 million-fold improvement in the reduction of nonspecific amplification. Journal of Molecular Diagnosis, 163-73. doi:10.1016/j.jmoldx.2013.10.004
Kit Specs
Components
Logix Smart™ COVID-19 Master Mix
Logix Smart™ COVID-19 Positive Control
Nuclease Free Water
Primary Packaging Details
Self-standing microcentrifuge tubes with screw cap lids are RNase, DNase, DNA, and pyrogen free. The tubes can withstand up to 20,000 x g centrifugation, vapor-phase liquid nitrogen storage, boiling, and autoclaving. Each lid has an O-ring. The black or amber tube is used for the master mix due to the light sensitivity of the mixture. The red cap is used to help identify the positive control mix.
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.