It is used to quantitatively detect the content of lipoprotein a in human serum in vitro.

Lipoprotein A is now considered to be an independent risk factor for atherosclerosis. Increased levels are seen in ischemic heart disease, cerebrovascular disorders, peripheral atherosclerosis, diabetes, kidney disease, connective tissue disease, etc. The significance of the reduction is unclear.

Lipoprotein a in serum samples binds to anti-human lipoprotein a antibody bound to the surface of latex particles to produce an antigen-antibody reaction and agglutinate latex particles. The agglomeration of latex particles increases the turbidity of the reaction solution, which is measured by the change of absorbance at 700 nm. A calibration curve of absorbance for concentration can be established by measuring a series of calibration products. The concentration of lipoprotein a in samples can be determined by comparing with the calibration curve.

1. Reagent preparation: liquid double reagent, no need to prepare direct use.

2. Test conditions:

The test environment is not more than 95% at temperature (15-37)degrees Celsius and relative humidity.

3. Calibration procedures:

3.1 The matching calibrator is used. The calibrator is liquid and can be used directly.

3.2 A series of calibration products were prepared by diluting the calibration products with deionized water according to the table below.

3.3 The calibration curve is established in the non-linear mode (see the attached page for the specific mode of different instruments).

3.4 Calibration Frequency: Normally, the determination should be calibrated at least once every two weeks. When the following situations occur (e.g. when the batch number of reagents used is changed, the instrument used is repaired, maintained or the key components are replaced, the quality control results drift or exceed the prescribed range, etc.), the determination should be calibrated again.

4. Quality control procedures:

Matching quality control products are selected. The quality control products are liquid and can be used directly. The measured value of quality control should be within the target value range. If the results deviate from the range, please follow the following steps:

4.1 Check parameter setting and light source correctness.

4.2 Check the cleanliness of the colorimetric cup and sampling needle.

4.3 Check whether the deionized water is contaminated or not. Bacterial growth will affect the test results.

4.4 Check the reaction temperature.

4.5 Check the validity of the kit.

5. Result calculation:

The absorbance difference (A2-A1) of the calibrator was calculated and the working curve of the absorbance-concentration of the calibrator was established.

The absorbance difference of the sample was calculated and the corresponding concentration value was read on the working curve.

1. appearance

Liquid double reagent: reagent 1 colourless to yellowish clarifying liquid; reagent 2 opalescent suspension.

Calibration: Colourless to light yellow clarifying liquid.

Quality Control Products: Colourless to light yellow clarifying liquid.

2. net content

The net content of the liquid reagent shall not be lower than the labeled volume.

3. Reagent blank absorbance

The blank absorbance of the reagent should not exceed 2.0 at 37 C, 700 nm wavelength and 1 cm optical path.

4. Analytical sensitivity

When the concentration is 150 mg/L, the range of absorbance change value (A) should be between 0.01 and 0.15.

5. Linear range

In the linear range of (5-800) mg/L, the linear correlation coefficient r is not less than 0.995. The linear relative deviation in the range of (80-800) mg/L is not more than (+15%) and the linear absolute deviation in the range of (5-80) mg/L is not more than (+12 mg/L).

6. repeatability

The coefficient of variation (CV%) of the results obtained by repeated testing of two samples with high and low concentrations should be less than 10%.

7. batches of difference

When the same sample was tested with different batch reagents, the relative range between batches should be no more than 15%.

8. accuracy

Recovery test: The recovery rate is between 85% and 115%.

9. Validity of quality control product assignment

The results were within the target range.