9 September 2009
Leigh Day & Co is acting for a young client whose diagnosis of cystic fibrosis, an inherited disease which affects the lungs and digestion, was delayed due to the Royal Free Hospital’s test for this fatal illness erroneously giving an ‘all clear’ on two separate occasions.
Our young client suffered periods of significant illness, including repeated bouts of pneumonia, over a period of around three years. But, although the tell-tale symptoms of cystic fibrosis were present, the Royal Free’s test for this disease, known as the “sweat test”, twice gave a negative result.
The “sweat test” is regarded as the gold standard for confirming the diagnosis of cystic fibrosis. This test measures the amount of salt (sodium and chloride) in sweat, as people with cystic fibrosis have a higher than normal amount of salt in their sweat (cystic fibrosis is caused by defects in a protein found in many tissues, including the sweat glands and, as a result the sweat glands do not work properly).
Sweat testing is a painless and non-invasive procedure, which usually takes about an hour. Small electrodes are placed on the lower arm or leg for around five minutes to stimulate the sweat glands to produce sweat. After this, a small collecting disc is placed on the stimulated area. The sweat collection takes up to 30 minutes and the sample is then sent to a laboratory for analysis.
If the levels of sodium and chloride salts are low, cystic fibrosis is unlikely. If the levels are high, the child will probably need a blood test to confirm the diagnosis of cystic fibrosis.
In our young client’s case, the Royal Free Hospital’s sweat test laboratory results showed a low salt reading on two separate occasions, which was interpreted as an ‘all clear’ for cystic fibrosis.
A subsequent positive sweat test (with a very high salt reading) by Great Ormond Street Hospital revealed our young client’s diagnosis of cystic fibrosis. As a result the Royal Free Hospital immediately suspended all “sweat testing” for cystic fibrosis because of the previously reported negative results. Our young client’s misdiagnosis instigated a Serious Incident Investigation at the Royal Free to look at their sweat testing processes. A biochemist from Great Ormond Street is also now reviewing the quality and effectiveness of sweat tests.
We understand that the Royal Free has been contacting parents of children tested in the hospital for cystic fibrosis since 2006, to check if they, too, were given incorrect results.
Our young client’s misdiagnosis has been publicised in the London Evening Standard
For more information please contact Gemma Hardiman
on 020 7650 1200.
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