Live Blood Analysis
Is live blood analysis (LBA) a legitimate diagnostic method or quackery? It depends upon who is using it and for what purpose. LBA uses a dark-field microscope to view fresh blood samples, in itself an uncontroversial process. Dark-field microscopes "do not differ substantially from microscopes already approved by the FDA for other diagnostic purposes," according to an US Office of Inspector General report. The controversy lies in the interpretation. Some practitioners use it to monitor the biological terrain. Some websites, which may or may not be run by a health practitioner, claim without substantiation that LBA can show the presence of specific diseases that can be remedied with supplements available at their site.
In dark-field microscopy, light shines from the side so that particles and objects on a slide reflect the light. As a result, the objects appear bright white against a dark background. The benefit of dark-field microscopy is that the resolution and contrast are better than bright-field viewing (in which light is shown through the slide) and less expensive than phase contrast. Phase contrast microscopes convert tiny phase shifts in light into contrast imaging as the light passes through a specimen. Like dark-field microscopy, phase contrast does not require the use of stains that kill cells. David R. Caprette at Rice University says, "Any time you wish to view everything in a liquid sample, debris and all, dark field is best. … Dark field is especially useful for finding cells in suspension [e.g. blood]." G. A. Jamjoom reported in 1983 that dark-field microscopy was useful for detecting differing forms of malarial parasites in unstained blood films: "The technique offers the distinct advantages of rapid diagnosis, increased sensitivity, and adaptability to field work."
While dark-field microscopy is an accepted tool, LBA is considered an "unestablished" laboratory test. In 2001, the US Office of Inspector General (OIG) published a report about the Centers for Medicare and Medicaid Service's ability to regulate laboratories conducting live blood cell analysis and other unestablished laboratory tests. All laboratory testing, including LBA performed in doctors' offices, should conform to the 1988 Clinical Laboratory Improvement Amendments (CLIA), according to the Office of General Counsel. This law set up quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results. Centers for Medicare and Medicaid Services is responsible for implementing CLIA.
Most of the 200 laboratories offering LBA, identified for the OIG report, did not have a CLIA certificate. Some doctors offering LBA "believe that LBA falls within the scope of their license to practice medicine and that it should not be regulated under CLIA" since Medicare does not pay for these tests. Other practitioners say they use LBA for research purposes only, which exempts a test from CLIA if patients are not informed of the test's results. "Most providers of unestablished tests with whom [OIG] spoke would like to be regulated by their peers and not by the CLIA program," says the OIG report. These providers would like to have "some checks and balances to protect the public from unscrupulous providers."
Like many other holistic CAM and integrative practices, however, LBA does not fit conventional medicine's reductionist paradigm that, rightly or wrongly, defines a "normal" range for isolated factors. Even physicians who operate laboratories that meet CLIA requirements for performing moderate and high complexity testing were unable to meet CMS requirements that would validate LBA as a precise, analytically sensitive test with established reference ranges. While LBA can provide useful information, it cannot accurately diagnose cancer. In 2005 German study, a health practitioner with several years of training in dark-field microscopy according to Enderlein examined the blood of 110 subjects. The practitioner correctly identified 3 of 12 patients with cancer in the group. The authors conclude: "Analysis of sensitivity (0.25), specificity (0.64), positive (0.09) and negative (0.85) predictive values revealed unsatisfactory results." Just because LBA is unreliable in diagnosing cancer doesn't mean that it isn't useful in other ways. The dark-field pictures that Majid Ali, MD, has shared in past issues of Townsend Letter and the pictures in Beverly Rubik's Weston Price diet study give objective information about a person's biology. At the very least, LBA can give skilled practitioners a easy way to evaluate overall terrain and to monitor progress. Contrary to assertions by the quackbusters, the OIG report doesn't condemn the use of LBA: "Nothing in this report should be construed as an endorsement or condemnation of any laboratory test."
The primary concern about LBA, according to the CDC, is the "potential harm that might occur when providers fail to recognize seriously ill patients." This concern is a realistic problem if LBA practitioners have little medical training, relying only on a correspondence course to interpret blood samples in order to sell products. For trained holistic practitioners, however, LBA may be a valuable assessment tool.
Caprette DR. Dark field viewing [Web page]. Rice University Introduction to Experimental Biosciences. www.ruf.rice.edu/~bioslabs/methods/microscopy/dfield.html. Accessed October 19, 2010.
El-Safadi S, Tinneberg HR, von Georgi R, et al. Does dark field microscopy according to Enderlein allow for cancer diagnosis? A prospective study. (English abstract, article in German.) Forsch Komplementarmed Klass Naturheilkd. June 2005;12(3):148–151. Available at: www.ncbi.nlm.nih.gov/pubmed/15985779. Accessed October 19, 2010.
Jamjoom GA. Dark-field microscopy for detection of malaria in unstained blood films.(abstract) J Clin Microbiol. May 1983;17(5):717–721. Available at: www.jcm.asm.org. Accessed October 19, 2010.
Office of Inspector General, US Department of Health & Human Services [online document]. CLIA regulation of unestablished laboratory tests. July 2001. www.oig.hhs.gov/oei/reports/oei-05-00-00250.pdf. Accessed October 19, 2010.
Rubin ZA. Live blood analysis: new diagnostic method or quackery? Proc UCLA Healthc. 2009;13. Available at www.med.ucla.edu/modules/wfsection/article.php?articleid=420. Accessed October 19, 2010.