Biomaterial Database

False-positive results with third-generation monoclonal hepatitis B surface antigen enzyme immunoassay. 1989

S Ratnam, and F Stead, and C B Head

Newfoundland and Labrador Public Health Laboratory, St. John's, Newfoundland, Canada.

Nonspecific hepatitis B surface antigen reactions with a third-generation enzyme immunoassay (Auszyme Monoclonal; Abbott Laboratories, North Chicago, Ill.) were investigated with 9,577 serum specimens in a clinical laboratory setting. Of the 196 serum specimens found reactive in Auszyme screen by the overnight procedure, 103 turned out to be true-positives, 71 were nonrepeatably reactive, and 22 were repeatably reactive but actually falsely positive (false-positive rate, 22 of 196, or 11.2%). Verification of the 196 screen reactives by the Auszyme 3-h incubation assay detected all but 4 true-positives, with a false-negative rate of 3.9% (4 of 103), and was negative for the rest. These observations reinforce the need for retesting all reactive specimens and confirming repeatedly reactive samples when the Auszyme Monoclonal test is used to detect hepatitis B surface antigen.

UI	MeSH Term	Description	Entries
D007124	Immunoenzyme Techniques	Immunologic techniques based on the use of: (1) enzyme-antibody conjugates; (2) enzyme-antigen conjugates; (3) antienzyme antibody followed by its homologous enzyme; or (4) enzyme-antienzyme complexes. These are used histologically for visualizing or labeling tissue specimens.	Antibody Enzyme Technique, Unlabeled,Enzyme Immunoassay,Enzyme-Labeled Antibody Technique,Immunoassay, Enzyme,Immunoperoxidase Techniques,Peroxidase-Antiperoxidase Complex Technique,Peroxidase-Labeled Antibody Technique,Antibody Enzyme Technic, Unlabeled,Enzyme-Labeled Antibody Technic,Immunoenzyme Technics,Immunoperoxidase Technics,Peroxidase-Antiperoxidase Complex Technic,Peroxidase-Labeled Antibody Technic,Antibody Technic, Enzyme-Labeled,Antibody Technic, Peroxidase-Labeled,Antibody Technics, Enzyme-Labeled,Antibody Technics, Peroxidase-Labeled,Antibody Technique, Enzyme-Labeled,Antibody Technique, Peroxidase-Labeled,Antibody Techniques, Enzyme-Labeled,Antibody Techniques, Peroxidase-Labeled,Enzyme Immunoassays,Enzyme Labeled Antibody Technic,Enzyme Labeled Antibody Technique,Enzyme-Labeled Antibody Technics,Enzyme-Labeled Antibody Techniques,Immunoassays, Enzyme,Immunoenzyme Technic,Immunoenzyme Technique,Immunoperoxidase Technic,Immunoperoxidase Technique,Peroxidase Antiperoxidase Complex Technic,Peroxidase Antiperoxidase Complex Technique,Peroxidase Labeled Antibody Technic,Peroxidase Labeled Antibody Technique,Peroxidase-Antiperoxidase Complex Technics,Peroxidase-Antiperoxidase Complex Techniques,Peroxidase-Labeled Antibody Technics,Peroxidase-Labeled Antibody Techniques,Technic, Enzyme-Labeled Antibody,Technic, Immunoenzyme,Technic, Immunoperoxidase,Technic, Peroxidase-Antiperoxidase Complex,Technic, Peroxidase-Labeled Antibody,Technics, Enzyme-Labeled Antibody,Technics, Immunoenzyme,Technics, Immunoperoxidase,Technics, Peroxidase-Antiperoxidase Complex,Technics, Peroxidase-Labeled Antibody,Technique, Enzyme-Labeled Antibody,Technique, Immunoenzyme,Technique, Immunoperoxidase,Technique, Peroxidase-Antiperoxidase Complex,Technique, Peroxidase-Labeled Antibody,Techniques, Enzyme-Labeled Antibody,Techniques, Immunoenzyme,Techniques, Immunoperoxidase,Techniques, Peroxidase-Antiperoxidase Complex,Techniques, Peroxidase-Labeled Antibody
D011933	Reagent Kits, Diagnostic	Commercially prepared reagent sets, with accessory devices, containing all of the major components and literature necessary to perform one or more designated diagnostic tests or procedures. They may be for laboratory or personal use.	Diagnostic Reagent Kits,Diagnostic Reagents and Test Kits,Diagnostic Test Kits,In Vitro Diagnostic Device,In Vitro Diagnostic Devices,In Vitro Diagnostic Medical Device,In Vitro Diagnostic Medical Devices,Kits, Diagnostic Reagent,Diagnostic Reagent Kit,Diagnostic Test Kit,Kit, Diagnostic Reagent,Kit, Diagnostic Test,Kits, Diagnostic Test,Reagent Kit, Diagnostic,Test Kit, Diagnostic,Test Kits, Diagnostic
D002353	Carrier State	The condition of harboring an infective organism without manifesting symptoms of infection. The organism must be readily transmissible to another susceptible host.	Asymptomatic Carrier State,Asymptomatic Infection Carrier,Inapparent Infection Carrier,Presymptomatic Carrier State,Presymptomatic Infection Carrier,Super-spreader Carrier,Superspreader Carrier,Asymptomatic Carrier States,Asymptomatic Infection Carriers,Carrier State, Asymptomatic,Carrier State, Presymptomatic,Carrier States,Carrier, Super-spreader,Carrier, Superspreader,Carriers, Super-spreader,Carriers, Superspreader,Inapparent Infection Carriers,Infection Carrier, Asymptomatic,Infection Carrier, Inapparent,Infection Carrier, Presymptomatic,Presymptomatic Carrier States,Presymptomatic Infection Carriers,Super spreader Carrier,Super-spreader Carriers,Superspreader Carriers
D005188	False Negative Reactions	Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)	False Negative Reaction,Reaction, False Negative,Reactions, False Negative
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
D006509	Hepatitis B	INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.	Hepatitis B Virus Infection
D006514	Hepatitis B Surface Antigens	Those hepatitis B antigens found on the surface of the Dane particle and on the 20 nm spherical and tubular particles. Several subspecificities of the surface antigen are known. These were formerly called the Australia antigen.	Australia Antigen,HBsAg,Hepatitis B Surface Antigen,Antigen, Australia
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man