Biomaterial Database

False positive tuberculosis skin test results. 1995

J C Grabau, and G T DiFerdinando, and L F Novick

Bureau of Tuberculosis Control, New York State Department of Health, Albany 12237-0627, USA.

The re-emergence of tuberculosis as a significant public health threat has led to greatly renewed activity in tuberculin skin testing to identify infected persons. However, even use of the preferred skin test technique (intradermal injection of purified protein derivative via the Mantoux method) can lead to either false positive or false negative results. Interpretation of a Mantoux test can be influenced by cross reactions with other mycobacteria, intertester variation, host-response variation, and product related problems. At least 25 apparent false positive purified protein derivative skin test reactions in New York State in 1992 appeared to be associated with lots of the derivative produced by one manufacturer. These unexpected skin test results led to examination of a product with an altered appearance that may have caused the unanticipated responses. After announcement of these false positive results to the press, the company removed the product from the market. Food and Drug Administration analysis later revealed particulate matter in vials of the suspected lots of purified protein derivative.

UI	MeSH Term	Description	Entries
D009518	New York	State bounded on the north by Lake Ontario and Canada, on the east by Vermont, Massachusetts, and Connecticut, on the south by the Atlantic Ocean, New Jersey, and Pennsylvania, and on the west by Pennsylvania, Lake Erie, and Canada.
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
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
D014374	Tuberculin Test	One of several skin tests to determine past or present tuberculosis infection. A purified protein derivative of the tubercle bacilli, called tuberculin, is introduced into the skin by scratch, puncture, or interdermal injection.	Test, Tuberculin,Tests, Tuberculin,Tuberculin Tests
D014376	Tuberculosis	Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM TUBERCULOSIS.	Koch's Disease,Kochs Disease,Mycobacterium tuberculosis Infection,Infection, Mycobacterium tuberculosis,Infections, Mycobacterium tuberculosis,Koch Disease,Mycobacterium tuberculosis Infections,Tuberculoses