Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Serum
Method Description Describes how the test is performed and provides a method-specific reference
The ORTHO HCV Version 3.0 ELISA Test System is a 3-stage test carried out in a microwell coated with a combination of recombinant hepatitis C virus (rHCV) antigen (c22-3, c200 and NS5). In the first stage, a diluted test specimen or appropriate controls are incubated in the test well for a specified length of time. If antibody reactive to any of the 3 antigens is present in the specimen, antigen-antibody complexes will be formed on the microwell surface. If anti-HCV is not present, complexes will not be formed. In the subsequent washing step, unbound serum proteins will be removed. In the second stage, murine monoclonal antibody conjugated to horseradish peroxidase is added to the microwell. The conjugate binds specifically to the human IgG portion of the antigen-antibody complexes. If antigen-antibody complexes are not present, the unbound conjugate will be removed by subsequent washing. In the third stage, an enzyme detection system composed of o-phenylenediamine (OPD) and hydrogen peroxide is added to the test well. If bound conjugate is present, the OPD will be oxidized, resulting in a colored end product. The amount of oxidized OPD, which has a yellow-orange color, is proportional to the amount of anti-HCV that is bound to the well. The enzyme reaction is stopped by the addition of sulfuric acid and the intensity of color developed is read using a spectrophotometer. Samples with absorbance values equal to or greater than the cutoff are considered initially reactive for antibody to HCV, but before they are reported as positive, the specimen is retested in duplicate.(Package insert: Hepatitis C Virus Encoded Antigen (Recombinant c22-3, c200, and NS5) ORTHO HCV Version 3.0 ELISA Test System Ortho Clinical Diagnostics, Inc. Raritan, NJ)
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.
Monday, Wednesday, Friday; Varies
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
Performing Laboratory Location The location of the laboratory that performs the test