Screening
Screening refers to a preliminary test that yields a
qualitative “Positive or Negative” result. Screening can be conducted with a
rapid test or using laboratory instrumentation (EIA, EMIT). Both rapid tests
and lab screens use the same testing technology, called immunoassay technology.
Screening technology is non-specific in that it does not differentiate among
the drug class. For example, a positive OPIATE result only indicates that there
is some opiate present. It does not show whether it is hydrocodone
(Vicodin), codeine (Tylenol 3), heroin, or a combination of these.
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Confirmation
Confirmation testing utilizes high complexity
instrumentation that yields a definite and specific result. Best practice for
confirmation testing involves using either a GC/MS or
LC-MS/MS. The results of a confirmation test provide an
absolute and definite result that indicates the specific drug/compound present
in the urine or oral fluid sample. Our lab partner utilizes all LC-MS/MS
instrumentation for confirmation testing, which is considered to be the platinum
standard. LC-MS/MS results are also defensible in court.
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Risks Of Re-Screening VS. Going Straight To Mass Spectrometry
Best practice confirmation protocol involves all positive
screens are confirmed using highly complex mass spectrometry (GC/MS or
LC-MS/MS). The initial screen can be a rapid (onsite) test or a laboratory
screen (EIA/EMIT) as both utilize the same technology. However, many lab protocols involve re-screening all samples that come into the lab for
confirmation testing before the specimen goes on the mass spec. While this
workflow can save the laboratory money, there are several significant
disadvantages of this protocol.
The first is that many samples arriving for confirmation
testing have already been testing using rapid/onsite (POCT) devices which have
yielded a preliminary and qualitative positive result. Holding the sample for
re-screening instead of going straight onto the GC/MS or LC-MS/MS can
delay turnaround time. Furthermore, the re-screen on the laboratory EMIT or EIA
does not provide any additional information and essentially is doing the same testing already conducted with the rapid/onsite (POCT) device.
The second significant disadvantage is that customers need
to ensure they know laboratory cut-off levels for re-screening. For
example, suppose a customer is testing onsite using a cup with buprenorphine at
5ng/mL and is sent to the lab and re-screened at 10ng/mL before going on
the mass spec. In that case, there is significant potential for a false-negative result. Best
practice should always require laboratory confirmation testing cut-offs to be
lower and more sensitive than the onsite devices.
In this case, if the lab re-screen is not sensitive enough,
the result could appear negative, when in fact, there is a drug present but below
the EIA/EMIT cut-off. As a result, the specimen never goes to GC/MS or LC-MS/MS, and drug use/abuse goes undetected and unconfirmed.
We strongly encourage all customers to ensure they are aware of the laboratory testing protocol and understand what they are getting and what is happening with the sample when it arrives at the lab. Contact us to request consultation around confirmation testing best practices.
Contact sales today to get set up for confirmation testing!