Do Tests Lie?

By: Gina D’Aiello, P.A., Regional Clinical Liaison, BioPlus Specialty Pharmacy

Imagine the joy of finally being cured of the life-threatening disease of hepatitis C. Now, imagine that after settling back into “normal” life for the next few months or years, another doctor (erroneously) tells you that you were never cured and still have the disease after all. Sadly, it’s a completely unnecessary roller coaster that happens more often than you’d think. It all goes back to a misunderstanding that some doctors and clinics have about test results in former hepatitis C patients.

In the seven years I spent working in a hepatitis C clinic in New York City, I had a front row seat to the evolution (and amazing improvements) of the hepatitis C treatment process. As many of you might recall, the first effective treatments for hepatitis C meant a grueling 48+ weeks of injections and oral medications that brought a myriad of side effects, along with only a 50/50 chance of a cure for even the most diligent of patients.

One of my patients back during that time of 48-week treatments, was a highly-dedicated young man named Steve* who faithfully took all of his medications during hepatitis C treatment, even though it made all of his hair fall out and brought on a deep depression. He knew about the 50% chance of being cured and we both hoped dearly that he would fall into that lucky half. His final lab test confirmed his cure. Steve joyfully got on with his life, moving to another state and finally feeling that he could commit to a new relationship, since he was no longer facing down the potential death sentence of hepatitis C.

Three years later, during a routine check by his new doctor, Steve was told that he was still infected with the hepatitis C virus (HCV) and had never been cured. When Steve showed up at my clinic, he was confused and, frankly, quite angry with me. It turned out that his new doctor ran the hepatitis C antibody test, and from the positive result, assumed Steve currently was infected with hepatitis C. This doctor was a generalist, not a specialist, and he made the all-too-common mistake of not realizing that the presence of hepatitis C antibodies simply meant Steve had been exposed to hepatitis C in his life.

All cured patients will test positive for antibodies, as the antibodies remain present for life. Thus, the antibody test did not necessarily mean that Steve currently had the disease. For a diagnosis of hepatitis C, the doctor should have run an HCV RNA test – a test I ordered right away.

As expected, this HCV RNA test was negative, confirming that Steve was still, in fact, cured of hepatitis C infection. We even ran the RNA test a second time, since the entire incident had been so upsetting for Steve and he wanted extra confirmation.

So while the antibody tests do not lie, they also do not tell the whole story. HCV patients post-treatment will always test positive for the HCV antibodies but only the RNA test can show whether there’s an active HCV infection. Fortunately today, most labs that run the antibody test are already including the RNA test at the same time; so what happened to Steve doesn’t happen as often as it used to.

The very important take-away from Steve’s story is this: A hepatitis C diagnosis cannot be made without the addition of an RNA test. To not take the lab work to this next level risks misdiagnosis and unnecessary trauma for patients.

*Not his real name

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