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77264

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government when the testing of the cerebrospinal fluid of patients suspected of having Lyme disease using the Trinity Biotech kit at the Health Protection Agency’s Lyme Borreliosis Unit began; how many patients' samples were tested in that way; and how many patients were recorded as being positive over that period of time.
tabling member printed	The Countess of Mar
uin	HL998
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The Trinity Biotech blot has been in use since 2007 by the former Health Protection Agency's Lyme Borreliosis Unit for testing cerebrospinal fluid (CSF) and proved very reliable. It has also been used in this way by other laboratories in Europe. However, CSF antibodies will not be present if there is no evidence of any other antibodies in the serum. Data is not collected centrally on specific samples from patients as the final diagnosis is made by the clinician on the basis of the test results and the clinical presentation.</p> answering member printed Earl Howe question first answered 24/07/2014 12:31:17 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77265

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether, in December 2011, the Clinical Pathology Accreditation Service was made aware of modifications by the Health Protection Agency’s Lyme Borreliosis Unit to the Trinity Biotech immunoblot kit to be used for testing human cerebrospinal fluid.
tabling member printed	The Countess of Mar
uin	HL999
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit (HPA LBU) was accredited by Clinical Pathology Accreditation who had access to, and was able to review, all the standard operating procedures of the unit.</p><p> </p><p>The Trinity Biotech Lyme Western Blot is a qualitative in vitro assay for the detection of Immunoglobulin (IgG or IgM) antibodies in human samples against specific antigens/proteins of <em>Borrelia afzelii, Borrelia garinii and Borrelia burgdorferi</em>. The Trinity Biotech Lyme Western Blot is intended as a confirmatory assay for use in testing human samples which have been previously found to be positive or equivocal using an Enzyme Immunoassay and Immunofluroescent Assay or other appropriate screening method. Positive second-tier results are supportive evidence of infection with <em>B. burgdorferi</em>. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to <em>B. burgdorferi</em>. The Trinity Biotech blot has been in use since 2007 by the former HPA’s LBU for testing cerebrospinal fluid (CSF) and proved very reliable. This technique has also been in use widely across Europe during this period as a diagnostic test using CSF as a sample to support the diagnosis of neuroborreliosis.</p> answering member printed Earl Howe question first answered 24/07/2014 12:32:59 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77266

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what evidence existed to show that the Health Protection Agency’s Lyme Borreliosis Unit (LBU) conformed with European Union and United Kingdom legislation for the use of the Trinity Biotech kit for <i>in vitro</i> testing when used with cerebrospinal fluid; and what testing was carried out by the LBU to verify that the use of that test kit was suitable, and sufficiently sensitive, for the detection of European and United Kingdom species of Borrelia infections in cerebrospinal fluid.
tabling member printed	The Countess of Mar
uin	HL1000
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit adhered to legislation related to diagnostic testing. The Trinity Biotech Lyme Western Blot technique was widely used in Europe at that time for serum and samples. Controls were run with each batch of the test to verify the tests accuracy and sensitivity. Quality assurance samples were run to ensure independent validation of the results.</p> answering member printed Earl Howe question first answered 24/07/2014 14:21:30 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77267

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether the Health Protection Agency’s Lyme Borreliosis Unit adhered to the Health Protection Agency's published guidelines on <i>Commercial and In-House Diagnostic Tests: Evaluations and Validations</i> in carrying out testing of cerebrospinal fluid of patients suspected of having Lyme disease using the Trinity Biotech kit.
tabling member printed	The Countess of Mar
uin	HL1001
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's (HPA) Lyme Borreliosis Unit adhered to the HPA’s published guidelines on Commercial and In-House Diagnostic Tests.</p> answering member printed Earl Howe question first answered 24/07/2014 13:24:08 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77268

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether the Health Protection Agency's Lyme Borreliosis Unit informed clinicians and patients of test results on cerebrospinal fluid in accordance with Medicines and Healthcare Products Regulatory Agency guidance in carrying out testing of cerebrospinal fluid of patients suspected of having Lyme disease using the Trinity Biotech kit.
tabling member printed	The Countess of Mar
uin	HL1002
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit (HPA LBU) informed requesting clinicians but not patients of the results on cerebrospinal fluid (CSF) and also provided a clinical interpretive service to the requesting clinician. Referring laboratories and clinicians managing patients with Lyme disease were aware of the limitations of diagnostic tests for serum and CSF through publications and educational meetings. It is the role of the requesting clinician to be guided by the interpretation of the laboratory result and to use these results in the light of the clinical presentation to make a diagnosis and a management plan for individual patients. It is also important to note that the former HPA’s LBU performed diagnostic tests on samples referred by other laboratories</p> answering member printed Earl Howe question first answered 24/07/2014 13:33:24 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar

77269

registered interest
date	10/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Lyme Disease
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether the Health Protection Agency's Lyme Borreliosis Unit informed clinicians and patients of test results on cerebrospinal fluid in accordance with Medicines and Healthcare Products Regulatory Agency guidance on devices used off-label.
tabling member printed	The Countess of Mar
uin	HL1003
answer	answer is ministerial correction date of answer 24/07/2014 answer text <p>The former Health Protection Agency's Lyme Borreliosis Unit informed requesting clinicians but not patients of the results on cerebrospinal fluid (CSF) and also provided a clinical interpretive service to the requesting clinician. There was no approved ‘on-label’ test for CSF at that time, which is why the use of this test was carefully controlled and its quality assured in each test run. It is the role of the requesting clinician to be guided by the interpretation of the laboratory result and to use these results in the light of the clinical presentation to make a diagnosis and a management plan for individual patients. In addition to the controls for the test, the CSF sample was run with the patient’s serum. If the patient had Lyme disease, serology would have demonstrated this and the patient treated appropriately for their clinical presentation whether the CSF was positive or negative.</p> answering member printed Earl Howe question first answered 24/07/2014 14:20:46 answering member 2000 label Biography information for Earl Howe
tabling member	1861 label Biography information for The Countess of Mar