Coag CA-620
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Hi,
I have a question how do you do reportable range for CA-620,it a coag instrument. CLIA wants me to do Reportable range but i only have normal patients. The CLSI guide says i can use Controls or patients. in my lab we only have normal patient how do i do low and high reportable ranges for coag?. Do i have to do dillutions or not and how much?
Thank you
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Hi Sandra,
Were you cited? As far as I know, reportable range or AMR are not applicable to coagulation tests. All you need to do is correlation against the lab instrument for accuracy and use controls for precision. If you already have normal patients, then use those results to verify your reference range.
Thank you Don!! yes i got cited. Don can i use ethe reportable range as my reference range because my reference range is lower than my reportable range. Again than you.
No, reportable range and reference range are not the same. Reportable range is how far you can accurately report results, which is much wider than the reference range and it does not apply to clot-based tests. On the other hand, reference range is a range of results that 95 percentile of the normal population would fall within.
I would use the main lab's reference range(s), then verify them by using 20 normal results from 20 normal individuals, whom appear healthy and not on any medication. If 18 out of the 20 fall within the lab's reference ranges, they are considered verified and you can use them as your reference ranges.
Don, can you use
Normal patient and the abnormal patient to Determine the reportable range. for example
Normal reference range
used only normal patient
pt- 9.0-11.6
ptt-21.3-29.3
reportable range
pt-9.3-34.5
ptt-22.5-91.5
the reportable range have combine data from normal patient and Abnormal patient.
Yes.
Thank you so much for your help