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Lipid Profile Strip

Total Cholesterol · HDL-C · LDL-C · Triglycerides

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Only for Professional Use
Rapid point-of-care lipid panel for cardiovascular risk stratification and longitudinal monitoring. Measures TC, HDL-C, LDL-C (calculated), and Triglycerides from a single capillary blood sample.
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Technical product

Lipid Profile Strip

Description

Lipid profile testing quantifies four core cardiometabolic analytes: total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG). Together, these markers provide the foundation for cardiovascular risk stratification, therapeutic decision-making, and longitudinal monitoring.

For near-patient workflows, lipid testing is highly actionable: the panel can be used for baseline screening, therapy initiation, response monitoring, and adherence conversations in pharmacy and outpatient settings.

Intended use

Quantitative measurement of Total Cholesterol (TC), HDL-Cholesterol (HDL-C), LDL-Cholesterol (LDL-C, calculated), and Triglycerides (TG) from capillary blood, venous whole blood, or plasma/serum samples.

Indicated for cardiovascular risk stratification, lipid-lowering therapy initiation and monitoring, residual risk assessment, and pharmacy-led cardiometabolic follow-up programmes.

Principle

Enzymatic lateral flow assay with 8-channel optical immunofluorescence reading via the Welleo Reader (LPM-101).

TC, HDL-C, and Triglycerides are measured directly from the strip signal. LDL-C and the TC/HDL ratio are calculated: LDL = TC − HDL − TG/5 (mg/dL) or LDL = TC − HDL − TG/2.2 (mmol/L).

A controlled UV beam eliminates subjective interpretation errors. Eight-channel synchronous calibration ensures consistent readings across samples.

Technical dossier

Laboratory and clinical details

Components
  • Total Cholesterol (TC) — direct enzymatic measurement
  • HDL-Cholesterol (HDL-C) — direct enzymatic measurement
  • LDL-Cholesterol (LDL-C) — calculated (Friedewald-derived)
  • Triglycerides (TG) — direct enzymatic measurement
  • TC/HDL ratio — calculated
  • Lipid profile test strips in sealed canister
  • Capillary transfer tubes
Materials provided
  • Lipid profile test strips (sealed canister)
  • Capillary transfer tubes
  • Instructions for use
Materials needed but not provided
  • Lipid Profile Reader (LPM-101)
  • Lancet device
  • Alcohol swabs
  • Gloves
Sample collection and preparation
  1. Document the patient's fasting status, current lipid therapy, recent acute illness, and major dietary or alcohol changes
  2. Clean the fingertip with an alcohol swab and allow to dry completely
  3. Perform capillary puncture with a lancet; wipe away the first drop of blood
  4. Collect the second drop using the capillary transfer tube — fill without squeezing to avoid sample dilution
  5. Apply the sample to the test strip immediately after collection
  6. Insert the loaded strip into the Welleo Reader without delay to minimise pre-analytical drift
  7. Analyse the capillary sample immediately after collection — do not store the loaded strip
  8. If using venous whole blood or plasma/serum, equilibrate the specimen to operating temperature before measurement if it was refrigerated
  9. Select the correct sample mode on the reader before inserting the strip: FB (capillary blood), VB (venous whole blood), SP (plasma/serum)
Storage and stability
  • Store strips in the original closed canister or sealed foil pouch under controlled temperature conditions
  • Once opened, use the strip canister within 3 months
  • Keep all testing materials within the operating and storage temperature ranges specified in the product insert
  • Do not use strips past the expiry date printed on the canister
Test procedure
  1. Power on the Welleo Reader and confirm it has passed its internal calibration check
  2. Select the appropriate sample mode: FB (capillary), VB (venous whole blood), or SP (plasma/serum)
  3. Collect the capillary blood sample following the sample collection protocol
  4. Load the test strip and apply the sample immediately
  5. Insert the strip into the Welleo Reader
  6. Wait for the result readout — the reader displays TC, HDL-C, LDL-C, TG, and TC/HDL ratio
  7. Review results against the reference intervals and record fasting status in the patient file
  8. Repeat unexpectedly extreme values; confirm with venous laboratory testing when results are near treatment thresholds or conflict with the clinical picture
Quality control
  • Repeat unexpectedly extreme values before taking clinical action
  • Confirm with venous laboratory testing when results are near major treatment thresholds
  • Confirm with laboratory testing when triglycerides are markedly elevated — Friedewald LDL-C accuracy decreases at high TG
  • Ensure the Welleo Reader has passed its internal calibration check before each testing session
  • Document QC runs in accordance with your laboratory's quality management procedures
Performance characteristics
  • Measuring range — TC: 2.59–12.93 mmol/L (100–500 mg/dL)
  • Measuring range — HDL-C: 0.39–2.59 mmol/L (15–100 mg/dL)
  • Measuring range — TG: 0.51–7.34 mmol/L (45–650 mg/dL)
  • LDL-C: calculated — LDL = TC − HDL − TG/5 (mg/dL) or LDL = TC − HDL − TG/2.2 (mmol/L)
  • Precision (CV): < 7.5% for TC, HDL-C, and TG in higher concentration intervals
  • Known interferences: high uric acid and high ascorbic acid may produce falsely lower results
  • Sample modes: capillary blood (FB), venous whole blood (VB), plasma/serum (SP)
Precautions
For professional use only. Not intended for self-testing by the general public.

High uric acid or high ascorbic acid concentrations may produce falsely lower TC, HDL-C, or TG measurements.

Nonfasting testing is acceptable for most routine risk assessment. Fasting is reserved for very high TG scenarios or when result interpretation is unclear.

Treatment decisions must integrate medical history, comorbidities, current medications, and local guideline requirements — do not act on point-of-care results alone.
Limitations
LDL-C is a calculated value using the Friedewald-derived formula. Accuracy decreases at high triglyceride concentrations — confirm with a direct LDL-C assay when TG is markedly elevated.

This test does not replace comprehensive laboratory evaluation where clinically indicated.

Interference from high uric acid or ascorbic acid may affect result accuracy. Refer to the product insert (LPM-101 Manual) for full interference tables.

How to use the Welleo tests