ANALYTES & METHOD DEVELOPMENT
It is important to consider the following two issues:
- Practice type and patient population dynamics impact a POL. If you are establishing your lab as a POL, your patient population necessarily dictates your lab requirements.
Your practice type and patient population are the primary drivers in considering your desired analyte panel(s). Note that analytes may require different methods (runs / panels) and that large panels are inherently more difficult to bring up and validate.
2. Market place and market place dynamics impact a clinical lab.
If you already have a selected physician practice clientele in place, you will want to start with plans that satisfy the needs of those practices. If you do not have clientele currently, you will want to conduct marketplace research to determine the types of practices receiving sampling. You will also want to determine if your panel(s) will provide a differentiating aspect from the rest of the market place.
Nature of analytes to be tested impacts number of methods to be developed beyond the most typical UDT compounds:
Designer drugs – These are a constantly shifting landscape of test development with regional overlays. It is important to consider if your treatment and patient population need this testing.
Synthetic marijuana – Synthetic marijuana doesn’t necessarily require a separate panel, but it does work out easier this way if a lab already has a large panel and is breaking things up. As stated earlier, this is something we recommend doing.
Alcohol – Requires a separate liquid chromatography column. The chemistries and nature of alcohol don’t allow it to be run on the same analytical column that is used with other compounds.
Barbiturates – Barbiturates, when they are chemically broken down, become negatively charged compounds simply because of their chemical structure and how they react to fragmentation. While they can be run with the positive mode ions (in the same panel), some labs prefer to run these by themselves in a negative ion mode panel. The results are generally cleaner this way.
Please work with your method developer and lab director to determine which analytes and cutoff levels are to be included.
There is what we consider to be a possible “red herring” argument sometimes discussed that argues against large, complicated methods. It goes as follows: Each run of a large method utilizes all analytes in your stock and the analytes are rather pricey. Furthermore, if you only wanted to address 25 of the 80-100+ analytes, that would result in a three-fold waste factor.
It should be pointed out, however, that this cost issue may be moot in your lab if you are not running a large number of samples each month. Since stock mixtures have limited shelf life, it is most probable that there will always be stock discarded, whether all-in-one or separate panels. So, having a large panel may not truly increase the costs for the standards used. Experience will tell you whether this is a concern or not.
In any event, it is important to select what your lab (and physician clients) require and to recognize that it may make greater sense to split the analytes into smaller runs / panels. Bear in mind that additional method development and validations are always possible as your lab evolves and as new concerns within the marketplace emerge.