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HPTN 035
Laboratory

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Study Information

HPTN 035 Protocol

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Operational Memos

  • Plasma Archive at Study Exit (09 Jun 2007)
  • Regulatory notes to file (01 Jun 2006)
    • The Central Lab needs to be informed as quickly as possible of any instrument problems/failures, QC and reagent problems.  SCHARP, FHI and the CL need to be made aware whenever your site puts in place any back up measures (such as using back-up labs and equipment or other sites' labs), switches in  reagents or kits, or updates normal ranges or toxicity grading based on a change of lab/instrument, reagent, or kit. SCHARP has QC checks in place that may need to be amended based on this information.  Please inform the Network Lab, SCHARP, and FHI within 24 hours of any such changes and provide the start dates of these measures to ensure that all necessary QC checks can be updated.
      Some reagent changes may require re-evaluation of your site's normal ranges and toxicity grading.  For example, if your PT reagent changes or has a differing ISI value, you will need to revalidate your ranges. If you have any questions regarding a normal range change, please contact the Network Laboratory (networklab@hptn.org).
    • Please ensure that your back up lab is providing you with a result form that lists the testing laboratories information, patient information, specimen date, reference ranges, and any critical value information. 

 

5% Blood Reference Image
Click on the thumbnail image below to see a full-size image of a tube containing 5% blood as a comparison for when to reject a urine specimen for testing for GC/CT on the ProbeTec.

wpe1.jpg (48244 bytes)

 

      
 

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This page was last updated: November 05, 2008