Do you anticipate a lot of controversy over which numbers should represent treatment thresholds?
Dr. Rosner: Since we didn’t have good methods and standards [until now], we have to correct all our normal ranges. Therefore, one of the things you’ll see [in the consensus statement] is that part of the goals is to establish normal ranges using proper methods.
Who would be opposed to standardization of testosterone testing, and on what grounds?
Dr. Rosner: Nobody can really oppose it in public, because it’s like motherhood, America, and apple pie—who wants to promote numbers that are meaningless? But the big argument against it is that it looks like it’s going to be more expensive to get it right in the short term. But who can argue for an inexpensive way to do things when the wrong answers are generated?
Are there any other grounds for objection?
Dr. Rosner: It’s tradition. It’s status quo. It’s what’s been acceptable in the past. For your quality control, if you get the same answer as everybody else who uses the same method you pass. But all the methods yield divergent answers so there’s no right answer in the truest sense of the word. That has to go away. Quality control has to be accuracy-based and not based upon a method—so called peer-based quality control.
Urologists have no reason to oppose standardization?
Dr. Rosner: No. They will be very supportive.
Can the standardized tests be analyzed in about the same amount of time as the conventional blood test?
Dr. Rosner: It depends. First of all, we don’t know what the ultimate testing method will be. The manufacturers who are making inexpensive but inaccurate tests will find it makes sense for them to make better tests for less money. That’s up to them. Right now the gold standard kind of a test is more expensive.
What is the gold-standard test?
Dr. Rosner: At the moment, the best and most sensitive method seems to be the mass spectroscopy-based measurements, but we are not married to this test. If someone comes up with an immunoassay-based test that’s just as accurate, that’s fine. But it’s got to be done not only quickly and cheaply, but accurately. Accuracy is the emphasis not the method.
At present, how widely used is mass spectroscopy?
Dr. Rosner: It’s generally available in large reference laboratories. Very few hospital-based laboratories have it. They will be faced with continuing with inaccurate testing, sending appropriate samples to reference laboratories, investing in new technologies, and hoping for the development of accurate methods based on the technologies already in their armamentarium.
It doesn’t sound like urologists will be affected by the testing method used.
Dr. Rosner: It should be transparent to the urologists. They take the same tube of blood and send it out. It just depends what happens at the other end. Of course, the urologists have a choice of where to send tests and what kind of test to ask for.
What sort of timeline are you looking at?
Dr. Rosner: The move toward accuracy-based testing has begun already; we hope to have everybody on board within the next couple of years: journals, third-party payers, the NIH, physicians, and so on. It’s been a struggle, but the end is just over the horizon.
Organizations endorsing consensus statement:
- American Association for Clinical Chemistry
- American Association of Clinical Endocrinologists
- Androgen Excess/PCOS Society
- American Society for Bone and Mineral Research
- American Society for Reproductive Medicine
- American Urological Association
- Association of Public Health Laboratories
- The Endocrine Society
- Laboratory Corporation of America
- North American Menopause Society
- Pediatric Endocrine Society (formerly known as Lawson Wilkins Pediatric Endocrine Society)
Source: The Endocrine Society