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77265
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL999 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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>
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T12:32:59.6647091Zmore like thismore than 2014-07-24T12:32:59.6647091Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this
77264
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL998 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T12:31:17.2846277Zmore like thismore than 2014-07-24T12:31:17.2846277Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this
77269
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1003 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T14:20:46.6606248Zmore like thismore than 2014-07-24T14:20:46.6606248Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this
77268
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1002 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T13:33:24.7350156Zmore like thismore than 2014-07-24T13:33:24.7350156Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this
77267
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1001 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T13:24:08.7476509Zmore like thismore than 2014-07-24T13:24:08.7476509Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this
77266
star this property registered interest false more like this
star this property date remove filter
star this property answering body
Department of Health more like this
unstar this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
unstar this property hansard heading Lyme Disease remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
The Countess of Mar more like this
star this property uin HL1000 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-07-24more like thismore than 2014-07-24
star this property 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> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-07-24T14:21:30.3706696Zmore like thismore than 2014-07-24T14:21:30.3706696Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1861
star this property label Biography information for The Countess of Mar more like this