Hi Pauline,

 

I spoke to WEQAS about this and Distribution W106 (and I think it looks like the current one - W107) was a sensitivity study and they only actually scored samples 1 and 2. They were going to issue further information regarding the results of the study in due course.

 

I have users of both the Alere and BioSign visual read tests and saw/am seeing similar mixed results & it seems to depend on whether the results are read at 3 minutes or 5 minutes.

 

Kind regards,

 

Kerry

 

Kerry Grant │Lead Biomedical Scientist – Point of Care Testing

Severn Pathology

North Bristol NHS Trust, Pathology Building, Southmead Hospital,

Southmead Road, Westbury-On-Trym, Bristol BS10 5NB

Tel: 0117 4148422 │ Fax: 0117 4149381

Website: www.severnpathology.com

 

 

 

 

 

Hi Mailbase

 

I note on above distribution some very unusual results.

All 4 samples in this distribution were in the low region, with samples 3 and 4 stated as containing 17 and 9 IU/L hCG respectively.

However I noted that for Sample 3, with a result of 17 IU/L, which would give a negative result in all the assays, 90% of all users reported readings of positive  This trend extends to the method groups with the greatest number of users.

A similar pattern is seen for Sample 4, supposedly with an hCG level of 9 IU/L.   The overall percentage of users reporting positive results for this sample was 72%, with the 2 largest method groups similar; 51% of Alere users reported as positive, and reported 51% , and Siemens reporting  a massive 91% as positive, rather than equivocal;  strange as latter not an eye read test.

These same trends are seen for all the other method groups with smaller numbers of participants, so unlikely to be a method based issue, possibly due to sample matrix effect?

 

We give our POCT users reports based on a traffic light system, interpreting in the light of the WEQAS reports, but it would seem that we cannot in all likelihood mark some of our ward areas as being "Red" having incorrect results, when they reflect the performance of so many other users.

Has anybody else encountered this?  We have written to WEQAS and await a response

 

Thanks

Pauline

 

Pauline Angel FRCPath

Principal Biochemist,

 

HSL Analytics/FM LLP

Barnet and Chase Farm Pathology

Barnet Hospital

Wellhouse Lane

Barnet

Hertfordshire EN5 3DJ

 

Tel +44 (0) 208  216 4338/4049 Ext; 64338/64049

www.hslpathology.com

 

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