Human T-Cell Lymphotropic Virus Types I and II (HTLV-I/-II) Antibody Confirmation, Serum
Method Description Describes how the test is performed and provides a method-specific reference
INNO-LIA HTLV I/II is a line immunoassay that uses well-defined antigens derived from man T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II) immunodominant proteins. The antigens used are either recombinant proteins or synthetic peptides, highly purified and fixed on a nylon membrane strip. The sequences are selected to allow the detection of antibodies with a wide specificity to all known isolates of the HTLV strains. The antigenicity exhibited by these proteins and peptides is either common to both HTLV-I and HTLV-II, or type-specific to 1 of the 2 viruses to allow confirmation and discrimination in a single assay. Two gag (p19-I/II, p24-I/II) and 2 env (gp46-I/II, gp21-I/II) bands are applied as non-type-specific antigens, which are used to confirm the presence of antibodies against HTLV-I/II. The type-specific antigens for HTLV-I (gag p19-I, env gp46-I) and for HTLV-II (env gp46-II) are applied to differentiate between HTLV-I and HTLV-II infections. In addition, 4 control lines are coated: 1 negative control (streptavidin), and 3 positive control lines, a strong (antihuman IgG), a moderate (human IgG), and a weak (human IgG) line.
This assay is based on the enzyme immunoassay principle. Specific anti-HTLV antibodies, if present in the clinical sample, will bind to the HTLV antigen lines on the strip. Subsequently, goat antihuman IgG antibodies labeled with alkaline phosphatase are added and will bind to any HTLV antigen-antibody complex previously formed. Incubation with a chromogenic substrate produces a dark brown color in proportion to the amount of specific antibodies present in the sample. The color development is stopped with sulfuric acid. If the sample contains no HTLV-specific antibodies, only a low background color develops.
Every sample is classified as negative, indeterminate, or positive, then further classified as HTLV-I, HTLV-II, or untypeable-positive according to the antibody band reactivity.(Package insert: INNO-LIA HTLV I/II Score kit. INNOGENETICS NV, Gent, Belgium, 25415 v10)
Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Wednesday; 3 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Stored serum 7 days
Performing Laboratory Location The location of the laboratory that performs the test