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Frequently Asked Questions
Laboratory Reporting
 
I received a laboratory report with the comment, "Specimens were received beyond the limits of stability." No test results were reported. Why did this happen and what can I do?

I am receiving laboratory reports from ICON Central Laboratories that only report some of the tests performed at the patient visit. Why is this occurring?

The clinical protocol that our site is involved in requires a drug screen with confirmation. We received a report from ICON Central Laboratories that reported the initial screen as "positive" and the confirmation testing as "pending." How do I know whether to enroll this patient or not?
 
Q I received a laboratory report with the comment, "Specimens were received beyond the limits of stability." No test results were reported. Why did this happen and what can I do?
 
A ICON Central Laboratories reviews the time that has elapsed from the specimen’s collection to its receipt in our laboratory. If this time period is longer than the period for which that specimen type is known to be stable, we will not perform the test. This is an important quality control procedure to ensure that accurate data is reported for the study. The protocol for your study may permit re-drawing the subject for that visit. Check with your study monitor, if you are not certain. Also, try to determine why the specimen may have been delayed reaching our laboratory. If you have concerns about timeliness of specimen pickups and deliveries by your courier, please contact our Site Service Specialists for assistance.
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Q I am receiving laboratory reports from ICON Central Laboratories that only report some of the tests performed at the patient visit. Why is this occurring?
 
A The sponsor of study has requested that ICON use a feature known as "partial reporting" for the study. This method of reporting is often selected when some tests required in the protocol take longer to process than others. For example, the study may require basic safety testing as well as microbiology testing. It may take several days to determine if the specimen is growing certain types of bacteria in order to issue an accurate laboratory report. However, safety test reporting is available within hours. To ensure patients’ safety, such tests are reported immediately so that appropriate medical monitoring and follow-up can occur. The tests requiring longer processing periods are then subsequently resulted on a separate report.
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Q The clinical protocol that our site is involved in requires a drug screen with confirmation. We received a report from ICON Central Laboratories that reported the initial screen as "positive" and the confirmation testing as "pending." How do I know whether to enroll this patient or not?
 
A

A positive screen is indicative that the subject screened positive for the drug class in question. No specific drug in the drug class can be identified from an initial screening test. Consequently, the specimen undergoes confirmatory testing to determine the specific drug or drugs present in the urine sample. In some cases, even though a screening test is positive, the confirming test may be negative. There are several reasons why this could occur:

  • The substance is below the detectable limit of the confirmatory test.
  • There are hundreds of drugs within a certain drug class, and we only test for the most commonly found substances; therefore, the subject could have been exposed to a drug in the class for which we do not run confirmatory tests.
  • Cross-reactivity with any number of other substances, such as herbal remedies, drugs from other classes or harmless substances, such as poppy seeds.

Regardless of the circumstances, you will most likely need to await the confirmatory results and consult with your medical monitor for the ultimate determination as to whether or not it is acceptable for the subject to continue in the study.

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