What is the Gold Standard Test?

Urine Test Cup
Urine Test Cup. Ann Cutting/Photographer's Choice/Getty Images

What is the Gold Standard?

The gold standard, in terms of testing, is the test that most accurately determines the presence of a disease. The test established as the gold standard may not actually be used in a clinical setting, because of expense, time, degree of invasiveness or expertise, but it is used to determine the sensitivity and specificity of other tests. However, it is important to realize that most times, not even the gold standard is perfect.

Therefore there is some ambiguity to those test characteristics.

In general, "gold standard" refers to the best available means of doing something. For example, randomized controlled trials are the gold standard of drug testing because they are the best way to determine if a drug is effective.

The "gold standard" refers to the most validated test that makes a diagnosis. The new test is compared to the most accurate test in use at the time.

Examples:  For a very long time, bacteria culture was unequivocally the gold standard for chlamydia testing, because even though it might miss some cases of chlamydia (false negative) it would never find a case that isn't there (false positive). However, in more recent years, other tests have started to fight for supremacy, including enzyme linked immunofluorescence assays (ELISA) and various nucleic acid amplification tests, such as those that are often done on urine samples.

Sources:

Baud D, Zufferey J, Hohlfeld P, Greub G. Performance of an automated multiplex immunofluorescence assay for detection of Chlamydia trachomatis immunoglobulin G. Diagn Microbiol Infect Dis. 2014 Mar;78(3):217-9. doi: 10.1016/j.diagmicrobio.2013.11.022.

Hadgu A, Dendukuri N, Hilden J. Evaluation of nucleic acid amplification tests in the absence of a perfect gold-standard test: a review of the statistical and epidemiologic issues. Epidemiology. 2005 Sep;16(5):604-12.

Martin DH, Nsuami M, Schachter J, Hook EW 3rd, Ferrero D, Quinn TC, Gaydos C. Use of multiple nucleic acid amplification tests to define the infected-patient "gold standard" in clinical trials of new diagnostic tests for Chlamydia trachomatis infections. J Clin Microbiol. 2004 Oct;42(10):4749-58.

Rafiei Tabatabaei S, Afjeiee SA, Fallah F, Tahami Zanjani N, Shiva F, Tavakkoly Fard A, Shamshiri AR, Karimi A. The use of polymerase chain reaction assay versus cell culture in detecting neonatal chlamydial conjunctivitis. Arch Iran Med. 2012 Mar;15(3):171-5. doi: 012153/AIM.0013.

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