Screening support, not a replacement for diagnosis.
Linkor is intended to support professional blood-screening pathways. Results should be interpreted by appropriately trained healthcare professionals alongside the individual’s clinical history, presentation and any other relevant information. Further diagnostic investigation or laboratory testing may be required where clinically indicated.
Appropriate positioning
Linkor can support screening and patient education and may provide information that assists a healthcare professional in deciding whether further review or referral is appropriate. Linkor should not be presented as a substitute for clinical judgement, medical diagnosis, diagnostic investigations or laboratory testing where these are clinically indicated.
Important clinical limitation
Abnormal, unexpected or concerning results should be managed in accordance with the provider’s clinical governance pathway. This may include verification, repeat testing where appropriate, communication with the patient’s general medical practitioner, onward referral or urgent escalation, depending on the result and the wider clinical context.
The calculated inflammatory indices, explained.
Dr Joseph Choukroun explains the systemic immune-inflammation index and systemic inflammation response index, how they are calculated from blood-count parameters, and how they may be considered as part of the wider screening picture. These indices are not standalone diagnostic tests for inflammatory disease.
What providers should have in place.
A safe screening service requires a clearly defined scope, trained and competent staff, informed consent, infection-prevention procedures, quality control, appropriate documentation and defined escalation pathways.
Defined service scope
Define whether Linkor is being used as part of a general screening service or to provide additional screening information before treatment. The result should not be presented as determining fitness or suitability for treatment.
Training and competence
Staff should be trained and assessed as competent in sample collection, analyser workflow, infection prevention and control, quality-control procedures, documentation, communication of results, test limitations and escalation pathways.
Escalation pathway
The provider should have a documented pathway identifying who is responsible for reviewing abnormal, unexpected or concerning results and how these will be communicated, referred or escalated.
Consent
Before testing, patients should understand the purpose of the screening, what is being measured, what the results can and cannot show, that screening does not provide a definitive diagnosis, and when further medical review may be needed. Consent should be documented in accordance with the provider’s policy.
Record keeping
Results, the information provided to the patient, any professional interpretation and any recommended follow-up or referral should be recorded in the provider’s normal clinical records.
Regulatory wording
Marketing and patient communication should describe Linkor as a professional blood-screening system. They should not imply that it diagnoses disease, rules disease in or out, determines suitability for treatment, replaces laboratory investigation or is approved or endorsed by the MHRA.
Regulatory status.
Linkor is registered with the Medicines and Healthcare products Regulatory Agency for placement on the market in Great Britain and is also registered for the European Union market under the applicable in vitro diagnostic medical device framework. Linkor is intended for professional blood-screening use and does not replace clinical judgement, diagnostic investigations or laboratory testing where clinically indicated. Local clinical governance, staff training, consent, record keeping and referral protocols remain the responsibility of the healthcare provider using the service.
Need governance documents?
Ask for consent wording and standard operating procedure support.