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LDL Cholesterol liquicolor
Pipette into cuvettes Reagent blank (RB) [CAL] /sample
Package Size
Water 10 μl ---
[REF] 10094 80 ml Complete Test Kit
10294 200 ml Complete Test Kit [CAL] / Sample --- 10 μl
[IVD] [ENZ] (R1) 750 μl 750 μl
Intended Use Mix gently and incubate exactly for 5 min. at 37°C
LDL CHOLESTEROL liquicolor is a direct homogeneous enzymatic assay for the [SUB] (R2) 250 μl 250 μl
quantitative determination of LDL-cholesterol (LDL). LDL is regarded as a lipid
component increasing the risk for coronary heart disease (CHD). Together with Mix gently, incubate at 37°C and read the absorbance A of [CAL] / samples
HDL-cholesterol (determined e.g., with HUMAN's HDL CHOLESTEROL liquicolor, against RB after 5 min. A [CAL] /sample = A [CAL] /sample – A RB
[REF] 10084) it is of diagnostic importance to estimate the individual risk for Manual Calculation
CHD. Calculate the concentration of the sample as follows:
Method A sample
The assay combines two steps: In the 1st step chylomicrons, VLDL and HDL Csample = C [CAL] x  (mg/dl; mmol/l)
cholesterol are specifically removed by enzymatic reactions. In the 2nd step A [CAL]
remaining LDL-cholesterol is determined by well established enzymatic
reactions, also employing specific surfactants for LDL.
Conversion factor: C (mg/dl) x 0.02586 = C (mmol/l)
Reactions Principle
Performance Characteristics
1st step: CHE + CHO Linearity: Up to 1000 mg/dl LDL-cholesterol (manual procedure).
HDL, VLDL,  cholestenone + H2O2 When used on analyzers, the linearity limit depends on the respective
and chylomicrons specific conditions application.
Catalase If the serum concentration of LDL exceeds the measuring range, dilute the
2 H2O2  2 H2O + O2
sample 1 + 1 with saline (0.9%) and repeat the test. Multiply the result by 2.
2nd step: CHE + CHO Interference: Dilute samples with triglycerides exceeding 1000 mg/dl with
LDL  cholestenone + H2O2
specific surfactants phys. saline (0.9%) 1 + 1 and multiply the result by 2.
H2O2 + Peroxidase Typical performance data can be found in the Verification Report, accessible via
chromogen  quinone dye www.human.de/data/gb/vr/su-ldl.pdf or
Contents www.human-de.com/data/gb/vr/su-ldl.pdf
[REF] 10094 10294 If the performance data are not accessible via internet, they can be obtained
[ENZ] (R1) 1 x 60 ml 1 x 150 ml free of charge from your local distributor.
[SUB] (R2) 1 x 20 ml 1 x 50 ml Interpretation of results
[CAL] 1 x 5 ml 1x 5ml Adult Treatment Panel III Classification:
[ENZ] (R1) Enzymes (red cap)
Good's buffer, pH 7.0 50 mmol/l Classification LDL Cholesterol concentrations
Magnesium chloride 20 mmol/l Optimal  100 mg/dl;  2.59 mmol/l
Cholesterol esterase 600 U/l Near or above optimal 100 – 129 mg/dl; 2.59 – 3.34 mmol/l
Cholesterol oxidase 500 U/l
Catalase 600 kU/l Borderline high 130 – 159 mg/dl; 3.36 – 4.11 mmol/l
TOOS 2.0 mmol/l High 160 – 189 mg/dl; 4.14 – 4.89 mmol/l
Preservatives < 0.1 % w/v Very high  190 mg/dl;  4.91 mmol/l
[SUB] (R2) Substrate (blue cap)
Peroxidase 5000 U/l These ranges are given for orientation only; each laboratory should establish its
4- Aminoantipyrin 4 mmol/l own reference range, as sex, diet, age, geographical location, and other factors
Good's buffer, pH 7.0 50 mmol/l affect the expected values.
Sodium azide 0.05 % Quality Control
Detergents 1.4 % w/v All control sera based on human serum with LDL-cholesterol values determined
Preservatives < 0.1 % w/v by this method can be employed.
[CAL] Calibrator (black cap) see label Automation
Human serum, lyophilized
Proposals to apply the reagents on analyzers are available on request. Each laboratory
Reagent Preparation and Stability
must validate the application in its own responsibility.
[ENZ] (R1) and [SUB] (R2) are ready for use.
Notes
Stability: After opening the reagents are stable up to 2 months when stored at 2...8°C.
Avoid contamination. Do not freeze. Do not mix caps. Protect [ENZ] (R1) from light. 1. False low LDL Cholesterol results may possibly occur with samples from patients
[CAL]: Reconstitute the content of the vial with exactly 5 ml distilled/deionised water,
treated with N-acetyl cysteine (NAC, treatment of paracetamol overdose), N-
close the vial and swirl carefully to dissolve all lyophilizate. Avoid foaming. Before use, acetyl-p-benzoquinone imine and/or Metamizole. Blood sampling should be
allow to stand at room temperature for at least 30 minutes, protected from light. performed before administration of metamizole.
Stability: 8 hours at 25°C, 7 days at 2...8°C. If required, the freshly prepared calibrator 2. The magnesium determination is disturbed by carryover of LDL CHOLESTEROL
can be aliquoted and frozen at -20°C for a maximum of 20 days. Freeze and thaw only liquicolor reagent.
once, mix carefully after thawing. Precautionary statements
Specimen P234 Keep only in original container.
Serum, plasma P260 Do not breathe dust/fume/gas/mist/vapours/spray.
Stability: We recommend a direct measurement after sampling, otherwise P262 Do not get in eyes, on skin, or on clothing.
store the serum at 2...8°C up to 5 days.
P281 Use personal protective equipment as required.
In plasma following concentrations of the anticoagulant should not be
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated
exceeded: EDTA-2Na <1000 mg/l; Na-citrate <5000 mg/l; heparin < 750 mg/l;
NaF < 2000 mg/l, Na-oxalate < 3000 mg/l. clothing. Rinse skin with water/shower.
Assay P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
Wavelength: Hg 578 nm, 555 nm, (546 to 604 nm)
Optical path: 1 cm P337+P313 If eye irritation persists: Get medical advice/attention.
Temperature: 37°C P401 Store in accordance with local/regional/national/international regulations.
Measurement: against reagent blank (RB), one blank per series is sufficient P501 Dispose of contents/container in accordance with local/regional/national/
Calibration international regulations.
Please use the calibrator included in the test kits or AUTOCAL, [REF] 13160 for All donor units of human origin have been tested for HBsAg, HIV and HCV-antibodies
automated procedures. and found to be negative using approved methods. However, the material should still
be regarded as potentially infectious.
Manual Procedure
Warm the reagents and the cuvette to 37°C. Temperature must be kept References
constant ( 0.5°C) for the duration of the test. 1. NIH Publication No. 01 3305, ATP III Guidelines AT-A-Glance, May 2001
2. Okada M. et al., J. Lab. Clin. Med. 132, 195 - 201 (1998)
3. In-house data

SU-LDL INF 1009401 GB 03-2022-16 |

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