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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART IV
- Regulation 38B
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The Medical Devices Regulations 2002, Section 38B is up to date with all changes known to be in force on or before 17 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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[F1Performance requirements for coronavirus test devicesU.K.
38B.—(1) The requirements that a coronavirus test device must meet for the purposes of regulation 38A(5) are set out in paragraphs (2) to (6).
(2) A coronavirus test device must be able to be put into service in accordance with this Part.
(3) A coronavirus test device that is an antigen test must have—
(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 60%;
(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.
(4) A coronavirus test device that is a direct molecular test must have—
(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 70%;
(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.
(5) A coronavirus test device that is an extracted molecular test must have—
(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 93%;
(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 97%.
(6) Where a coronavirus test device is also intended to detect the presence of anything other than a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the requirements in paragraphs (2) to (5) apply only in relation to its performance in detecting the presence of that viral antigen or viral ribonucleic acid (RNA).
(7) In this regulation and in regulation 38C—
“antigen test” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);
“direct molecular test” means an in vitro diagnostic medical device which—
(a)
is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
(b)
does not use a preliminary step of purification and concentration;
“extracted molecular test” means an in vitro diagnostic medical device which—
(a)
is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
(b)
uses a preliminary step of purification and concentration;
“sensitivity”, in relation to a coronavirus test device, means the proportion of true positives that are correctly identified by the test, calculated using the equation—
“specificity”, in relation to a coronavirus test device, means the proportion of true negatives that are correctly identified by the test, calculated using the equation—
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