Hi,
I chatted to Theresa about this on the 'phone following her posting but just wanted to let you know about a similar problem we has with the strip version of the Invitech Pregnancy Test kit ( INV-FHC-101) the early part of last year.
We received several reports of 'false negative results' with this kit. On investigation using QC material we could never find an issue with the performance of the test strips and had pretty much put it down to user error (incorrect timing, poor lighting, wrong sample...). We then had a negative result for a patient who presented with classic ectopic symptoms. Luckily the ED Registrar thought to request a serum hCG and that, with the ultrasound, confirmed the diagnosis. The kit was withdrawn and returned to me. Using QC material, I tested the remaining strips and identified two problem strips - one would have been 'invalid' as no lines appeared but on the other strip there was only one line. On closer inspection the second line was actually just behind the handling area of this strip but could quite easily have been missed when testing a patient sample. Hopefully you'll be able to spot the 'dodgy' strip on the attached photo.
We reported this to Invitech and the reason for the 'dodgy' test (where the test area was offset) given to us was that it "was down to a manufacturing error, where the accessory part and the absorbent part were stuck in the opposite position. My colleague there is extremely apologetic and the company has further tightened QA and training procedures as a result."
We also reported it to the MHRA as we felt sure this couldn't be an isolated incident but, despite reiterating our findings to them several times, the only outcome we had was that Invitech were extending the read time for their test strip pregnancy test kit (which obviously would have made no difference to this result!). We're not even aware that the MHRA sent out an alert regarding the kit or whether Invitech withdrew the affected lot number.
We changed to the BioSign hCG Pregnancy Test with immediate effect. This is still visual read but we'll also be looking at the possibility of implementing readers.
Hope this is helpful,
Kerry
Kerry GrantLead 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 3238380 Fax: 0117 3238377
Website: www.severnpathology.com
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-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of STOPPARD Terry (RF4) BHR Hospitals
Sent: 12 January 2015 17:01
To: [log in to unmask]
Subject: Re: Invitech Pregnancy Tests
The product code - INV-FHC-102
The batch that was withdrawn was Lot no. W00140619
Terry
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Perry Leslie
Sent: 12 January 2015 16:32
To: [log in to unmask]
Subject: Re: Invitech Pregnancy Tests
Can I ask Theresa and Terry which product code and lot number are you both using?
Les
Les Perry PhD FRCPath
Consultant Clinical Scientist
T : 0208 401 3000 x4062
E : [log in to unmask]
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of STOPPARD Terry (RF4) BHR Hospitals
Sent: 12 January 2015 15:54
To: [log in to unmask]
Subject: Re: Invitech Pregnancy Tests
Hi Theresa,
We have recently had some issues with the Invitech pregnancy test cassettes. In particular, one batch was found to be showing positives only very weakly? And one case of a double positive line? This was reported to Invitech, and this batch was recalled. In addition, there have been a couple of recent cases of incorrect test results, however, on investigation these were probably the result of the hook effect?
We are currently reviewing the use of manual read pregnancy tests and are looking to move to automated readers soon.
WR,
Terry Stoppard
POCT Co-ordinator
BHR University Hospitals Trust
King George Hospital
Tel: 0208 970 8472
Mob: 074327 34635
DD 8472
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Theresa Hornsby
Sent: 12 January 2015 15:28
To: [log in to unmask]
Subject: Invitech Pregnancy Tests
Can I ask users of Invitech pregnancy tests if they are seeing any problems with them?
Our users are reporting curved lines, slipped lines or getting incorrect results.
Theresa
POCT Co-ordinator
Norfolk & Norwich University Hospital
Barking, Havering & Redbridge University Hospitals NHS Trust: Working to make our hospitals better.
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