CG is a major component of human bile acid, which is synthesized liver cells combining cholic acid and glycine. The liver plays a physiological role through the enterohepatic circulation. Under normal circumstances, the liver can effectively absorb more than 99% of CG in portal venous blood and re-secrete bile and the amount entering the systemic circulation is <1%.
Intended Use:
For the quantitative detection of CG in human serum, plasma or whole blood in vitro. They are for professional use only.
CG is a major component of human bile acid, which is synthesized liver cells combining cholic acid and glycine. The liver plays a physiological role through the enterohepatic circulation. Under normal circumstances, the liver can effectively absorb more than 99% of CG in portal venous blood and re-secrete bile and the amount entering the systemic circulation is <1%. Studies have shown that the content of CG in patients with cirrhosis, acute and chronic hepatitis is significantly higher than that in normal people. CG is one of the sensitive indexes to evaluate the circulatory function of hepatocytes and hepatobiliary substances.
Storage & Package:
1.The strip is stable for 18months (while sealed in an aluminum foil pouch) if stored at 2 - 30°C. Do not freeze.
2.After the strip is opened, the test should be performed in 1 hour.
3.After resolving, the quality control is stored at 2-8°C for 24 hours away from the light.
4.The date of manufacture is detailed in the label.
Name | Composition |
Strip | Consisting of a cartridge and a strip, the test strip comprises a sample pad, a glass fiber (coated with a fluorescent particle-CG antibody conjugate, fluorescent particle -IgY antibody conjugate), a nitrocellulose membrane (the detection zone is coated with a CG –BSA conjugate, and the quality control zone is coated with a chicken IgY), absorbent paper, PVC board. |
Buffer | Main component is phosphate buffered saline (PBS). 200ul/tube. |
QC(Freeze-dried products. Optional) | The target value range: 2 Levels:（2.5±0.5）μg/mL （20±5）μg/mL |
Magcard | Have Calibration curve information of this batch reagents. |
Manual | To describe basic information, usage methods and precautions |
1 Test/Box; 10 Tests/Box; 25 Tests/Box; 50 Tests/Box; 100 Tests/Box.QC (Optional): 0.5mL×1; 1mL×1
Test Procedure:
1. Please read this instruction manual, the instruction manual of the dry fluorescence immunoassay analyzer and incubator before use. Analyzer power adapter output is 12V, and incubator power adapter output is 24V. Please do not mix the two adapters. The cassette should be carried out under the room temperature for a while before testing.
2. Reading card: Reading card: Insert the magcard into the analyzer and click “read card” on the machine. (only read one time for the same item of the same batch) Then select the calibration curve for the corresponding sample type.
3. Sampling: To take 20 µl sample to buffer to shake and mix in 5-10s.
4. Add samples: Take out the strip from the bag and use a pipette to take 80 µl of the step 3 sample and add it to the sample well of the strip.
5. Test: Connect power supply for incubator. (Temperatures has been set . Please do not adjust the temperature). After sample added, please insert the strip into incubator for 15 mins incubation. Please strictly control the time for 15 mins. After incubation, please insert the strip into analyzer to read the result.(For D10 analyzer, click “quick test”).
6. The dry fluorescence immunoassay analyzer measures and analyzes the optical signal to quantify the concentration of the substance to be tested.
Product Performance:
Appearance: The appearance of the reagent should be neat and tidy, and the text symbol should be clearly marked. There is no leakage. The test strip is intact. Freeze-dried products are colorless or pale yellow after redissolution.
Analytical Sensitivity: 0.2µg/mL
Linear Range: 0.2～40µg/mL, and the correlation coefficient R≥0.990.
Repeatability (Precision): Repeated testing （2.5±0.5）μg/mL and （20±5）μg/mL samples, the result coefficient of variation CV≤15%.
Inter batch difference: Testing （2.5±0.5）μg/mL and （20±5）μg/mL samples, the relative difference R≤15%.
Accuracy: The recovery rate is 85-115%.
QC product evaluation effectiveness: test results of QC products in test kit boxes are all within QC range.
Inter bottle difference of QC products: CV≤15%.