Dubious Diagnostic Tests

Stephen Barrett, M.D.
June 10, 2019

Four things should be considered when evaluating whether a test is useful:

  • Analytic validity: Does the test accurately measure the component of interest?
  • Clinical validity: Does the test detect or predict the presence or absence of a recognized clinical disease or predisposition to such a disease? Relevant parameters include sensitivity and specificity.
  • Clinical utility: What is the likelihood that using the test will lead to an improved health outcome?
  • Ethical, legal and social implications: These include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment, and the cost-effectiveness of testing.

Most of the tests listed below have little or no diagnostic value. A few are legitimate for some purposes but are used improperly for others. Those marked with an asterisk (*) are done primarily or exclusively by chiropractors. If you encounter a practitioner who uses or abuses any of these tests, you should seek advice elsewhere. Practitioners who do live cell analysis, biological
terrain assessment, dental sensitivity testing, and cytotoxic testing in their offices are required to have CLIA approval for high-complexity testing.
Except for freestanding commercial laboratories, blood banks, hospitals, and large medical offices, very few facilities have high-complexity approval.
Only a few states restrict the use of unestablished laboratory tests. Nevertheless, if you encounter a practitioner who does these four
tests and is not obviously running a laboratory, please ask your state laboratory department to investigate.

The FDA has expressed concern about laboratory-developed tests (LDTs), which it defines as tests performed only by the laboratories that develop them. CLIA, the primary laboratory regulator, examines how tests are performed but does not consider how their results are interpreted. Widely used diagnostic tests require FDA clearance or approval, but the agency has not attempted to regulate LDTs. In 2014, the FDA expressed concern about LDTs that are used to guide treatment decisions and drafted a regulatory framework that would includepre-market review. In 2015, it reported on 20 LDTs, noting that some of them can cause patients to undergo unnecessary treatments and potentially delay diagnosis of their true condition. Unfortunately, it has taken no further action in the direction of greater regulation.

Blood Tests
Saliva Tests
Urine Tests
Hair Tests
Stool Tests
  • Secretory Immunoglobulin A, also called secretory IgA or sigA
Dubious Devices
Imaging Procedures
Physical Examination Procedures
Skin Tests
Genetic Testing
Internet Testing

Questionable (Nonstandard) Laboratories
Federally Sanctioned Laboratories [1996] [1997] [1998] [1999] [2000]
[2001] [2002] [2003] [2004] [2005] [2006] [2007] [2008] [2009] [2010]
[2011] [2012] [2013] [2014] [2015] [2016] [2017] [2018]

This page was revised on June 10, 2019.