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Self-monitoring of blood cholesterol (SMBC) for patients with hyperlipidaemia using point of care testing devices - J Bolodeoku MBBS MSc MBA DPhil (Oxon) FRCPath

BloodCurrently Point of Care Testing (POCT) has revolutionized the self-testing of a number of parameters such as blood pressure, glucose and lipids. POCT provide significant benefits to patients:

  • The tests are usually minimally invasive as most of them require only a small amount of blood usually collected from the finger and requires no sample preparation1.
  • The tests are usually completed within 5 minutes, leading to a reduction in the result turnaround time, thereby allowing a quicker decision being made2,3.
  • The patient being involved with their testing improves their compliance, adherence to treatment and therapeutic control4,5.
  • The self-testing also allows the patients to make less visits to the laboratory or GP practice to have their bloods taken4,5,6.

Well-known examples are the self-monitoring of blood pressure (SMBP) in patients with hypertension and self-monitoring of blood glucose (SMBG) in patients with diabetes. Studies have shown that (SMBP) results in small, but significant reductions in blood pressure and better adherence to treatment7. SMBG has been shown to be helpful in 4 distinct ways: First, both patient and clinician are able to ascertain high or low levels of glucose and thereby make the necessary therapeutic adjustments. Second, SMBG provides the patients the chance to detect or confirm whether they have a hyper or hypo incident. Third, the SMBG devices also provide patient education and disease management information. Fourth, SMBG helps motivate the patients8.

In the management of patients with hyperlipidaemia, it is expected that after initiating pharmacological interventions such as statins, fibrates, bile acid sequestrants and more recently, PCSK9 inhibitors, the patients are expected to have follow up laboratory tests done at 6 weeks, -3 months, 6 months and yearly. However, the practice is that patients have these blood tests done for their next visit to the outpatient lipid clinic and usually requires the patients to visit their local hospital laboratory or General Practice (GP) to have their bloods taken and the lipids estimated prior to their visit to the outpatient lipid clinic. The incorporation of self blood testing of cholesterol devices should be able to improve the initiation of pharmacological intervention. There are a number of point of care cholesterol measuring systems on the market, such as Accutrend Plus, BeneCheck Plus, CardioChek PA, Cholestech LDX, Veri-Q and 3in1, these measuring devices range from portable handheld lipid blood testing devices to compact desktop analysers that can measure a number of lipid fractions and ratios on whole blood, plasma or serum collected from the finger or venous blood.

The method of analysers use reflectance or biosensor technology with single-use, disposable, dry reagent test strips, rotors or cassettes. The lipid fractions and ratios can be measured individually or as multiple tests: a full lipid profile would consist of total cholesterol, HDL-Cholesterol and triglyceride. Calculated lipid fractions and ratios such as total cholesterol/HDL ratio and calculated LDL-Cholesterol can be estimated with some of the measuring systems9,10. Two cholesterol point of care testing devices have been Cholesterol Reference Method Laboratory Network (CRMLN) certified: Cholestech LDX® System (Alere, UK) and Professional CardioChek PA (Polymer Technology Systems Inc, Indiana, US, BHR Pharmaceuticals Ltd., Nuneaton, UK)10. Lipid and lipoprotein concentration vary during the normal course of daily activity. Studies have demonstrated that within person variability is sufficient to make an individually move in and out of the pre-defined risk categories defined by the respective lipid guidelines. There are a number of factors that influence lipids and one important factor to take into consideration is the within person day to day variation. The ranges of within person variation biological variability described in the literature show the coefficient of variation percent (CV%) for total cholesterol as 2.5% - 10.9%, for HDL-cholesterol as 3.6% - 12.4%, for LDL-cholesterol as 7.8% - 13.6% and for triglycerides as 12.9% - 40.8%11-14.

Recently, the within person day to day variation in a healthy volunteer was assessed using one of the cholesterol testing POCT devices, the CardioChek PA and the CV% fell within the CV% described in the literature: total cholesterol 9.3%, HDL-cholesterol 7.0%, LDL-cholesterol 13.7% and triglyceride 23.11%15 demonstrating that these devices could be used for monitoring. Recently, there are even new devices such as the elemark™ which in addition to measuring a range of cholesterol parameters, have connectivity options like Wi-Fi and the 3G HSPA, the data can also be synced with cloud storage. This enables sharing the information with a third party such as the patients care giver and allow real time monitoring.

Self-monitoring of blood cholesterol (SMBC) using devices such as the elemark™ potentially will be helpful in 4 distinct ways to the NHS:

  1. Helping both the patient and clinician in being able to ascertain high or low levels of glucose and thereby make the necessary therapeutic adjustments.
  2. Provide the patients the chance to more regularly detect or confirm whether their lipids are decreasing or increasing, without having to visit the lipid clinic.
  3. Allows patients to monitor lipid levels remotely and clinicians to track and monitor.
  4. The SMBC devices will also provide patient education and disease management information in providing trends of their lipid profiles and help motivate the patients.

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Hammond J, Wentz P, Statland BE, Phillips JC, Winkel P. Daily variation of lipids and hormones in sera of healthy subjects. Clinica Chimica Acta 1976; 73 (2) : 347 – 352

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Bookstein L, Gidding SS, Donovan M, Smith FA. Day to day variability of serum cholesterol, triglyceride and high density lipoprotein cholesterol levels. Arch Intern Med 1990; 150 (8) : 1653 – 1657

Bolodeoku J. Self-monitoring blood cholesterol (SMBC) testing: within person day to day variation in a healthy volunteer. Medical Research Archives 2017: 5 (9) : 1 - 5

Content provided by J Bolodeoku MBBS, MSc, MBA, DPhil (Oxon), FRCPath

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Lipid Clinic, Department of Cardiology
Basingstoke & North Hampshire Hospital
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