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Apolipoprotein A1, APO A1
Turbidimetric Monoreagent for the Pipetting Scheme

Quantitative Determination of APO A1 Bring [RGT] /R1 to 37°C prior to measurement.

Zero the instrument with distilled water.
Package Size
[REF] 11101 2 x 30 ml Monoreagent/R1 Pipette into cuvettes:
[IVD] [RGT] /R1 1000 µl
[STD] or Sample 5 µl
Intended Use Mix and immediately insert cuvette into the photometer. Read the
Apo A1 is the main protein component of HDL (High Density Lipo-protein). absorbance A1 at 340 nm after 10 seconds. Incubate 10 minutes at 37°C
Apo A1 activates lecithin cholesterol acyltransferase which catalyses the and read the absorbance A2.
esterification of cholesterol. The resulting esterified cholesterol can then
be transported to the liver, metabolised and excreted. ∆A sample/[STD] = A2 sample/[STD]- A1 sample/[STD]

Persons with atherosclerotic vascular changes frequently exhibit Calculation

decreased levels of Apo A1. Even if the concentrations of apo-lipoprotein B The APO A1 concentration in the sample is calculated by interpolation of
are normal, a decreased Apo A1 level may be a risk factor for its absorbance (∆A) from the calibration curve.
atherosclerotic processes. Decreased levels of Apo A1 also occur in
dyslipoproteinemias, acute hepatic cirrhosis and insulin-treated patients. Performance Characteristics
Linearity: 40 - 300 mg/dl
Method
Apo A1 antigens in sample or standard cause immunological No prozone phenomenon observed up to 600 mg/dl.
agglutination with the anti-Apo A1 antibodies in the reagent. The extent Linearity and prozone limit depend on the analyzer and application used.
of agglutination is proportional to the Apo A1 concentration in the sample Typical performance data can be found in the Verification Report,
and can be measured by turbidimetry. accessible via
Contents www.human.de/data/gb/vr/tu-apoa1.pdf or
[RGT] 2x APO A1 Monoreagent (R1) www.human-de.com/data/gb/vr/tu-apoa1.pdf
30 ml Polyclonal anti-human APO A1 antiserum (goat)
in phosphate buffered saline Reference Values
Polymer enhancer PEG 3% Men: 115 - 190 mg/dl
Sodium azide 0.095 % Women: 115 - 220 mg/dl
Additional material recommended but not supplied with the kit This range is given for orientation only. Each laboratory should establish
[REF] 11104 its own reference values.
[STD] For 2 x APO A1 / B Standard Automation
1 ml Recalcified human plasma, lyophilised. Proposals to apply the reagents on analyzers are available on request.
Sodium azide 0.095 % Each laboratory has to validate the application in its own responsibility.
APO A1 / B concentrations traceable to WHO/IFCC
reference preparations are listed on the label Quality Control
All control sera with APO A1 values determined by this method can be
Reagent Preparation and Stability employed.
[RGT] /R1 is ready for use, while the [STD] is lyophilised material; both are
stable until the expiration date stated on the label, when stored at 2...8°C. Safety Notes [RGT] / R1, [STD]
Stability after opening is 60 days for the [RGT] /R1, stability after All patient specimens, calibrators and controls should be handled as
reconstitution is 7 days for the [STD] when stored at 2...8°C. Avoid potentially infectious. All donor units of human origin have been tested
contamination and freezing. Refer to the leaflet for [STD] for for HBsAg, HIV and HCV-antibodies and found to be non-reactive using
reconstitution instructions approved methods. All materials of animal origin avoid many risks
associated with the use of human serum (e.g. Hepatitis B and C, HIV).
Calibration Nevertheless, all material of human or animal origin should still be
For quantitative measurement a calibration curve has to be established treated as potentially infectious material.
for which we recommend [STD] ([REF] 11104, for 2 x 1 ml). P234 Keep only in original packaging.
Prepare dilutions of [STD] using physiological saline (0.9%) as diluent. Use P260 Do not breathe dust/fume/gas/mist/vapours/spray.
saline (0.9%) as zero calibrator. P262 Do not get in eyes, on skin, or on clothing.
P281 Use personal protective equipment as required.
Specimen P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated
clothing. Rinse skin with water/shower.
Serum P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Stability: 7 days at 2...8°C Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/attention.
6 months at – 20°C (thaw once only) P401 Store in accordance with local/regional/national/international
regulations.
Assay P501 Dispose of contents/container in accordance with
Wavelength: 340 nm, Hg 334/365 nm local/regional/national/international regulations.
Optical path: 1 cm References
Temperature: 37°C 1. Rifai N. et al., Ann. Clin. Lab. Science 18, 429 (1988)
Measurement: against water (increasing absorbance) 2. Gordon T. et al., Ann. J. Med. 62, 707 (1977)
3. Dati F. et al., Lab. Med. 13, 87 (1989)

TU-APOA1 INF 1110101 GB 05-2021-12 |

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