The initial analysis of sid (b)(6) was judged "positive" with interpretive program (ip) message "thrombocytopenia" alerting to sample abnormality.The sysmex xn-3000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are laboratory-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify of possible sample specific abnormalities.Further verification of accurate results is recommended prior to reporting to the clinician.Chapter 15 - technical information, section 15.2 - system limitations and interfering substances, informs of situations where results may be affected.For plts, the ifu notes: "if any of the following are present, the system may erroneously report a low platelet count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant platelets." plt clumping was noted upon smear review.Plt clumps can be caused by abnormal proteins in the patient's plasma that cause plts to clump when exposed to edta anticoagulant.The longer a sample is exposed to edta, more clumping can occur.When the sample with sodium citrate anticoagulant was analyzed, the analyzer generated a higher plt result as compared to the edta sample.The higher plt result generated from the sodium citrate anticoagulant sample supports the possibility of edta induced pseudothrombocytopenia.The investigation determined the analyzer performed as designed.
|