Trilogy Biotechnology LLC

HDL- CHOLESTEROL
225 Madinah St., 305 Commercial Complex, Amman, Jordan Quantitative Determination of HDL.
Post code 11954,
Tel: +962 79 8599872,
Email: info@[Link]
Precipitation Method.
Website: [Link]
For professional in vitro diagnostic use only.

INTENDED USE CALCULATION

Precipitation reagent for the determination of HDL-cholesterol in Serum/ Plasma: Follow the instructions of the total cholesterol insert
human serum or plasma with the CHOD-POD method. Calculated LDL-cholesterol (Friedewald):
LDL-c = Total cholesterol - HDL-c - (TG/5)
GENERALITIES
Low HDL-cholesterol is a strong independent predictor of coronary
heart disease. In ATP III , low HDL cholesterol is defined categorically QUALITY CONTROL
Normal and abnormal control sera of known concentration should be
as a level < 40 mg/dL (1.04 mmol/L), a change from the level of < 35
analyzed routinely with each group of unknown samples.
mg/dL in ATPII (1993). Low HDL cholesterol is used as a risk factor to
estimate 10-year risk for coronary heart disease, having several
EXPECTED VALUES
causes: elevated triglycerides, overweight and obesity, physical
• Low Risk: >55 mg/dL, for men/ > 65 mg/dL for women.
inactivity, and type 2 diabetes. Other causes are, cigarette smoking,
very high carbohydrate intakes (> 60% of calories), and certain drugs • Standard risk: 35-55 mg/dL, for men/ 45-65 mg/dL for women
Anabolic steroid and pregestational agents. • Increased risk : <35 mg/dL, for men/ <45 mg/dL for women.
Each laboratory should establish a range of expected values based on
TEST PRINCIPLE its patient population and, if necessary, determine its own reference
This technique uses a separation method based on the selective interval. For diagnostic purposes, results should always be assessed
precipitation of apolipoprotein-B containing lipoproteins (VLDL, LDL together with the patient's medical history, clinical examination and
and (a) Lpa) by Phosphotungstic acid/MgCl2, sedimentation of the other results.
precipitant by centrifugation, and subsequent enzymatic analysis of
high density lipoproteins (HDL) as residual cholesterol remaining in PERFORMANCE
the clear supernatant. PRECISION:
Low Level: Samples= 20; Average = 33.9; S.D. = 0.85; CV = 2.51%.
REAGENT COMPOSITION
High Level: Samples = 20; Average = 75.8; S.D. = 0.89; CV = 1.18%.
Reagent ACCURACY:
Phosphotungstic acid 14 mmol/L
Magnesium chloride 2 mmol/L
A comparison between this method (x) and a certified method of trade
Standard (y) gave the following correlation:
Cholesterol value on label y= 0.9944x – 1.2346 r =0.995

STORAGE, PREPARATION AND SHELFLIFE SENSITIVITY: 2 mg/dL.

Liquid and ready to use reagents, stable until the expiry date shown, if LINEARITY: 275 mg/dL.
stored as indicated on the label and avoid contamination, evaporation
and prolonged exposure to direct light. Do not freeze the reagents. PRECAUTIONS
Discard the reagent if signs of deterioration appear, such as the R: Harmful if swallowed, in contact with skin or inhaled. It causes
presence of particles and turbidity or failure to recover the values of severe skin burns and eye damage. Causes damage to organs.
certified control sera. After opening the bottles, it is advisable to in case of contact of reagents with the operator, you must apply the
withdraw the necessary volume, to immediately close the bottles and following first aid: In case of contact with eyes, rinse immediately with
store them in the fridge to avoid contamination, degradation from plenty of water and seek medical advice. After contact with skin, wash
direct light and evaporation. immediately with plenty of water. Wear suitable protective clothing,
gloves and eye/face protection.
SAMPLE COLLECTION AND PREPARATION
Serum ,EDTA or heparinized plasma. INTERFERENCES
No interference was observed by Triglycerides do not interfere up to
Avoid hemolysate. Separate the serum from the clot quickly.
concentration of 4000 mg/dL. A list of drugs and other interfering
Serum / Plasma stability: 7 days at 2-8C° C; 3 months at -20° C.
substances with HDL cholesterol determination has been reported
by Young et. Al.
TEST PROCEDURE
Bring reagents and samples to room temperature. LITERATURE
Precipitation: - Naito H K. High-density lipoprotein (HDL) cholesterol. Kaplan A et
Sample 1000 µL al. Clin Chem The C.V. Mosby Co. St Louis. Toronto. Princeton 1984;
Reagent 100 µL 1207-1213 and 437.
- Mix. Let stand for 10 min at 20 – 25°C. - Grove T H. Effect of reagent pH on Determination of HDL
- Centrifuge for 20 minutes at 4000 g. Cholesterol by precipitation with Sodium Phosphotungstate-
- After centrifugation separate the clear supernatant from the magnesium Clin Chem 25:560,1979.
precipitate within 20 hour and determine the cholesterol - Young DS. Effects of drugs on Clinical Lab. Tests, 4th ed AACC
concentration using Trilogy Cholesterol CHOD-POD Reagent Press,1995.

CC-JO-HDLP-01/ REVISION A /DATE: 14/01/2025 Page | 1

- Young DS. Effects of disease on Clinical Lab. Tests, 4th ed. AACC
2001. USED SYMBOLS
- Burtis A. et al. Tietz Textbook of Clinical Chemistry, 3rd ed. AACC
1999. In Vitro Diagnostic Medical Device
- Tietz N W et al. Clinical Guide to Laboratory Tests, 3rd ed. AACC Manufacturer
1995. Date of Manufacture
Catalogue Number
Batch Code
Use by YYYY-MM (MM = end of month)
Operator's Manual; Operating Instructions
Keep away from Sunlight
Keep away from Rain
Temperature Limit
Caution
Do not use if Package is Damaged
Do Not Re-Use
Contains Sufficient for <N> Tests

CC-JO-HDLP-01/ REVISION A /DATE: 14/01/2025 Page | 2