Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: early 2007, inratio: 2.
1, lab: 8.
5, mean: 5.
3, confidence limits: unable to be determined.
Per internal procedure, the mean of the inratio meter and comparative system inr were calculated.
The confidence limits cannot be determined.
The readings are considered inaccurate based on "area outside the acceptance region" table.
The results are considered discrepant within the context of the documented variability for inr testing.
Therefore, further testing is required at this time.
In troubleshooting found that the pt has antiphospholipid antibody syndrome.
It was explained that possible interferences may be due to the varying levels of the antibodies.
Pts condition may cause the discrepant errors.