Can you trust the Test?

Dr. Weeks wonders:  Are you infected with any of these agents?

– HCV (hepatitis C virus)

– HIV (human immune deficiency virus

– HPV (human papilloma virus)

 

If you think so, pray tell, how do you know it is true?

Did the doctor tell you that you had the disease?

Or – bear with me here – did the doctor actually only tell you that you tested positive for the disease?

 

What is the difference, you say?

Well, let’s start with the fact that testing is not fool proof. Termed “false positive” results, your test could declare you infected when you are only the victim of mistakenly swapped samples, contaminated samples, or simple mis-interprestations of test results. Any vigilant doctor practicing for more than a decade has seen all these errors. One startling case involved a wonderful lady who tested positive for HIV in 1996 and shocked and terrified, she travelled to see me in 1996 from New York City because she knew people who had benefited from my Corrective Care for HIV patients. What was curious was that she was a healthy active 39 year old happily married heterosexual wife of a loving husband – both of whom swore to be monogamous. She was in the lowest risk category for HIV. So I explained to her that we should retest the HIV to be certain that it really was her sample which tested positive. Upon retesting, her blood showed negative to HIV. She was relieved but also upset that retesting wasn’t suggested by her NYC doctor which would have saved her the time and expense of travelling to a specialist. We can never know what happed for certain with her blood test in NYC (I suspect a mistakenly swapped sample by a careless lab technician) but I did not offer her any treatment for a non-existent infection and I sent her home delightfully perplexed to NYC with the suggestion that she retest in a month. She called me after that test, quite relieved to report negative results.

 

But even if your test results do come back positive, it is worth reading the frank disclaimers on these tests which comprise the standard of care for these diseases. It will appear unbelievable to you,  but indeed this is what the package inserts disclaim to doctors using these tests:

 

 

Disclaimers accompanying viral load detection of HCV, HIV, HPV.

 

Roche’s AmpliPrep/COBAS TaqMan HCV Test”¨

”¨“The COBAS AmpliPrep/COBAS TaqMan HCV Test is not intended for use as a screening test for the presence of HCV in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.””¨”¨

http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060030c.pdf

 

 

Roche’s AmpliPrep/COBAS® TaqMan® HIV-1 Test”¨

”¨“The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.””¨

http://molecular.roche.com/assays/Pages/COBASAmpliPrepCOBASTaqManHIV-1Testv20.aspx

 

Roche cobas® HPV Test High-Risk HPV with 16/18 Genotype”¨”¨

“This test is not intended for use as a screening device for women under age 30 with normal cervical cytology. The cobas® HPV Test is not intended to substitute for regular cervical cytology screening. The cobas HPV Test is not intended for use in determining the need for treatment (i.e. excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia.”

http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100020c.pdf

 

 

The art of medicine requires treating the patient and not the lab result. All these tests require that the doctor exercise her or his clinical

If you have tested positive and yet you feel and look healthy, then perhaps you should wonder whether the problem may indeed not be in you after all,  but actually be in the testing process itself.

 

 

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Dr. Weeks wonders:  Are you infected with any of these agents? – HCV (hepatitis C virus) – HIV (human immune deficiency virus – HPV (human papilloma virus)   If you think so, pray tell, how do you know it is true? Did the doctor tell you that you had the disease? Or – bear with…
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