Lipoprotein (a), Lp(a) Pipetting Scheme

Carefully mix [RGT] before use

Latex-Enhanced Turbidimetric Test for the Bring the reagents to 37°C prior to measurement.
Quantitative Determination of Lipoprotein (a) Zero the instrument with distilled water.
Pipette into cuvettes.
Package Sizes
[REF] 11105 2 x 25 ml Buffer diluted Sample/ diluted [STD] 30 μl
[BUF] 800 μl
1 x 3 ml Latex reagent
Mix and insert cuvette into the photometer. Read the absorbance A1 at
[IVD] 570 nm after 10 seconds.
[RGT] 60 μl
Intended Use
Lp(a) is a human serum protein whose structure is close to that of LDL. Its Mix and incubate for 10 minutes at 37°C. Read the absorbance A2.
density lies between those of LDL and HDL. ΔA Sample / [STD] = A2 Sample/ [STD] - A1 Sample/ [STD]

The Lp(a) concentration in blood varies from almost undetectable levels to Calculation
more than 100 mg/dl. Differences in Lp(a) levels are genetically The Lp(a) concentration in the sample is calculated by interpolation of its
determined and will not be much influenced by lifestyle. absorbance (ΔA) from the calibration curve.
The presence of high Lp(a) levels in serum is a significant marker for an Reference Values
increased risk of atherosclerosis and coronary heart disease. Up to 30 mg/dl.
Epidemiological studies have shown, that people with normal serum This range is given for orientation only, each laboratory should establish
cholesterol and a serum Lp(a) level over 30 mg/dl have a double risk of its own reference range.
coronary heart disease. The risk is 8 times higher if LDL and Lp(a) levels are
simultaneously elevated. Performance Characteristics
Linearity: 6 – 200 mg/dl
Method
Lp(a) in sample or standard cause agglutination of the latex particles The performance characteristics are stated in the individual application
coated with anti-Lp(a) antibodies. The agglutination is proportional to the sheets.
Lp(a) concentration in the sample and can be measured by turbidimetry. Typical performance data can be found in the Verification Report, acces-
sible via:
Contents
www.human.de/data/gb/vr/tu-lpa.pdf or
[REF] 11105
www.human-de.com/data/gb/vr/tu-lpa.pdf
[BUF] 2 x 25 ml Buffer pH 7.4
Sodium chloride 0.9 % Quality Control
Detergent 0.05 % All control sera with values determined by this method may be employed.
Sodium azide 0.095 %
[RGT] 1 x 3 ml Latex Reagent Notes
1. [BUF], [RGT] and [STD] contain sodium azide (0.095%). Do not swallow.
Latex particles coated with
Avoid contact with skin and mucous membranes.
anti-Lp(a) antibodies (goat) 0.5 %
Glycine buffer pH 8.3 2. All sera used for the manufacture of the standard have been tested for
Bovine serum albumin 1% HBsAg, HIV- and HCV-antibodies and found to be negative using
Sodium azide 0.095 % approved methods. However, the material should still be regarded as
potentially infectious.
Additional material recommended but not supplied with the kit
[REF] 11107 References
1. Philips et al., Biochem. 32, 3722 (1993)
[STD] 2 x 0.5 ml Standard
liquid, stable human serum basis 2. Ezratty et al., Biochem. 32, 4628 (1993)
Sodium azide 0.095 % 3. Wang et al., Clin. Chim. Acta 207, 73 (1992)
Lp(a) concentration is stated on the label. 4. Grainger et al., Science 260, 1655 (1993)
5. Scott J., Nature 341, 22 (1989)
Reagent Preparation and Stability
The reagents are ready to use and stable, if unopened, up to the given
expiry date, when stored at 2...8°C. [BUF] and [RGT] are stable after TU-LPA INF 1110501 GB 04-2008-11 |
opening for 60 days, [STD] for 30 days, when stored at 2...8°C. Avoid
contamination and freezing.

Calibration
For quantitative measurement a calibration curve has to be established
for which we recommend the Lp(a) Standard ([REF] 11107, 2 x 0.5 ml
[STD]).

Specimen
Serum, plasma (EDTA).
Dilute samples/controls 1:10 with saline (0.9%). After sampling, the test
should be performed within 8 hours. If the test cannot be carried out
within this time, the samples can be stored in a tightly sealed container at
-20°C for 6 months.

Assay
Wavelength: 570 nm, Hg 578 nm (550 - 600nm)
Optical path: 1 cm
Temperature: 37°C
Measurement: against water (increasing absorbance)

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