Biomaterial Database

Covid-19 Molecular Diagnostic Testing - Lessons Learned. 2020

Jeffrey Shuren, and Timothy Stenzel

From the Food and Drug Administration, Silver Spring, MD.

UI	MeSH Term	Description	Entries
D011024	Pneumonia, Viral	Inflammation of the lung parenchyma that is caused by a viral infection.	Pneumonias, Viral,Viral Pneumonia,Viral Pneumonias
D003257	Consumer Product Safety	The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.	Safety, Consumer Product,Product Approval,Product Approvals,Product Safety, Consumer
D005189	False Positive Reactions	Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)	False Positive Reaction,Positive Reaction, False,Positive Reactions, False,Reaction, False Positive,Reactions, False Positive
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000073640	Betacoronavirus	A genus of the family CORONAVIRIDAE which causes respiratory or gastrointestinal disease in a variety of mostly mammals. Human betacoronaviruses include HUMAN ENTERIC CORONAVIRUS; HUMAN CORONAVIRUS OC43; MERS VIRUS; and SEVERE ACUTE RESPIRATORY SYNDROME-RELATED CORONAVIRUS. Members have either core transcription regulatory sequences of 5’-CUAAAC-3’ or 5’-CUAAAC-3’ and mostly have no ORF downstream to the N protein gene.	HCoV-HKU1,Human coronavirus HKU1,Pipistrellus bat coronavirus HKU5,Rousettus bat coronavirus HKU9,Tylonycteris bat coronavirus HKU4,Betacoronaviruses
D000086382	COVID-19	A viral disorder generally characterized by high FEVER; COUGH; DYSPNEA; CHILLS; PERSISTENT TREMOR; MUSCLE PAIN; HEADACHE; SORE THROAT; a new loss of taste and/or smell (see AGEUSIA and ANOSMIA) and other symptoms of a VIRAL PNEUMONIA. In severe cases, a myriad of coagulopathy associated symptoms often correlating with COVID-19 severity is seen (e.g., BLOOD COAGULATION; THROMBOSIS; ACUTE RESPIRATORY DISTRESS SYNDROME; SEIZURES; HEART ATTACK; STROKE; multiple CEREBRAL INFARCTIONS; KIDNEY FAILURE; catastrophic ANTIPHOSPHOLIPID ANTIBODY SYNDROME and/or DISSEMINATED INTRAVASCULAR COAGULATION). In younger patients, rare inflammatory syndromes are sometimes associated with COVID-19 (e.g., atypical KAWASAKI SYNDROME; TOXIC SHOCK SYNDROME; pediatric multisystem inflammatory disease; and CYTOKINE STORM SYNDROME). A coronavirus, SARS-CoV-2, in the genus BETACORONAVIRUS is the causative agent.	2019 Novel Coronavirus Disease,2019 Novel Coronavirus Infection,2019-nCoV Disease,2019-nCoV Infection,COVID-19 Pandemic,COVID-19 Pandemics,COVID-19 Virus Disease,COVID-19 Virus Infection,Coronavirus Disease 2019,Coronavirus Disease-19,SARS Coronavirus 2 Infection,SARS-CoV-2 Infection,Severe Acute Respiratory Syndrome Coronavirus 2 Infection,COVID19,2019 nCoV Disease,2019 nCoV Infection,2019-nCoV Diseases,2019-nCoV Infections,COVID 19,COVID 19 Pandemic,COVID 19 Virus Disease,COVID 19 Virus Infection,COVID-19 Virus Diseases,COVID-19 Virus Infections,Coronavirus Disease 19,Disease 2019, Coronavirus,Disease, 2019-nCoV,Disease, COVID-19 Virus,Infection, 2019-nCoV,Infection, COVID-19 Virus,Infection, SARS-CoV-2,Pandemic, COVID-19,SARS CoV 2 Infection,SARS-CoV-2 Infections,Virus Disease, COVID-19,Virus Infection, COVID-19
D000086402	SARS-CoV-2	A species of BETACORONAVIRUS causing atypical respiratory disease (COVID-19) in humans. The organism was first identified in 2019 in Wuhan, China. The natural host is the Chinese intermediate horseshoe bat, RHINOLOPHUS affinis.	2019 Novel Coronavirus,COVID-19 Virus,COVID19 Virus,Coronavirus Disease 2019 Virus,SARS Coronavirus 2,SARS-CoV-2 Virus,Severe Acute Respiratory Syndrome Coronavirus 2,Wuhan Coronavirus,Wuhan Seafood Market Pneumonia Virus,2019-nCoV,2019 Novel Coronaviruses,COVID 19 Virus,COVID-19 Viruses,COVID19 Viruses,Coronavirus 2, SARS,Coronavirus, 2019 Novel,Coronavirus, Wuhan,Novel Coronavirus, 2019,SARS CoV 2 Virus,SARS-CoV-2 Viruses,Virus, COVID-19,Virus, COVID19,Virus, SARS-CoV-2,Viruses, COVID19
D000086742	COVID-19 Testing	Diagnosis of COVID-19 by assaying bodily fluids or tissues for the presence of COVID-19 antibodies, SARS-COV-2 antigens or the VIRAL RNA of SARS-COV-2.	2019 Novel Coronavirus Disease Testing,2019 Novel Coronavirus Testing,2019-nCoV Disease Testing,2019-nCoV Infection Testing,2019-nCoV Testing,COVID-19 Diagnostic Testing,COVID-19 Virus Testing,COVID19 Testing,COVID19 Virus Testing,Coronavirus Disease 2019 Testing,Coronavirus Disease-19 Testing,SARS Coronavirus 2 Testing,SARS-CoV-2 Testing,Severe Acute Respiratory Syndrome Coronavirus 2 Testing,2019 nCoV Disease Testing,2019 nCoV Infection Testing,2019 nCoV Testing,2019-nCoV Disease Testings,2019-nCoV Infection Testings,2019-nCoV Testings,COVID 19 Diagnostic Testing,COVID 19 Testing,COVID 19 Virus Testing,COVID-19 Diagnostic Testings,COVID-19 Testings,COVID-19 Virus Testings,COVID19 Testings,COVID19 Virus Testings,Coronavirus Disease 19 Testing,Coronavirus Disease-19 Testings,Diagnostic Testing, COVID-19,Disease Testing, 2019-nCoV,Infection Testing, 2019-nCoV,SARS CoV 2 Testing,SARS-CoV-2 Testings,Testing, 2019-nCoV,Testing, 2019-nCoV Disease,Testing, 2019-nCoV Infection,Testing, COVID-19,Testing, COVID-19 Virus,Testing, COVID19,Testing, COVID19 Virus,Testing, Coronavirus Disease-19,Testing, SARS-CoV-2,Virus Testing, COVID-19,Virus Testing, COVID19
D012680	Sensitivity and Specificity	Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	Specificity,Sensitivity,Specificity and Sensitivity
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.