α1-MG  Storage Conditions and Shelf Life

1. The shelf life is 12 months, if kept airtight in dry, dark places at 2℃—8℃.
_____________________________________________ α 1 -MICROGLOBULIN REAGENT KIT
2. Stable for 30 days at 2℃—8℃ after opened.
_________________________ (LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD)  For Instrument
 Product Name DIRUI CS-300A/B, CS-400A/B, CS-600A/B, CS-800A/B, CS-1200, CS-1300B, CS-1600, CS-6400, CS-T240 /T300
1. Common name: α 1-MICROGLOBULIN REAGENT KIT （ LATEX ENHANCED IMMUNOTURBIDIMETRIC Auto-Chemistry Analyzer; Hitachi automatic biochemical analyzer; Toshiba TBA-40FR, TBA-120FR, TBA-2000FR
METHOD） automatic biochemical analyzer; Abbott C8000, C16000 automatic biochemical analyzer; Backman DxC 600, DxC 800,
2. English name: α 1-MICROGLOBULIN REAGENT KIT （ LATEX ENHANCED IMMUNOTURBIDIMETRIC AU480, AU680, AU2700, AU5400, AU5800 automatic biochemical analyzer. The company has application parameters of
METHOD） each type of automatic biochemical analyzer for the user to refer to.
3. English abbreviation:α1-MG  Sample Requirement
 Package Specification 1. The sample is serum; the blood sample should be fresh, without hemolysis.
Product Specification 2. If it cannot be measured immediately, please put it at -20℃ for preservation and avoid repeated freezing and thawing.
R1:1×20mL R2:1×5mL Calibration sample:1mL（Optional）  Detection Method
R1:1×40mL R2:1×10mL Calibration sample:1mL（Optional） 1. Reagent preparation: reagent 1 and reagent 2 are liquid; can be used directly.
R1:2×40mL R2:1×20mL Calibration sample:1mL（Optional） 2. Detection conditions:
R1:4×40mL R2:1×40mL Calibration sample:1mL（Optional） Detection temperature 37℃ R1 consumption 240μL
R1:4×50mL R2:1×50mL Calibration sample:1mL（Optional） Main wavelength 600nm—700nm R2 consumption 60μL
R1:4×50mL R2:2×25mL Calibration sample:1mL（Optional）
Optical path of cuvettes 1.0cm Sample consumption 2μL
R1:4×80mL R2:4×20mL Calibration sample:1mL（Optional）
Absorbance range 0A—3.2A Reaction time 300s
 Intended Use
The reagent kit is used for the in vitro quantitative detection of the content of α1-MG in human serum samples. Detection mode 2-point end point method Reaction direction Positive reaction
Serum α1-MG can sensitively reflect the changes in glomerular filtration function. Under normal circumstances, about 3. Operation procedure
99.9% of the free α1-MG passing the glomerular filtration membrane is reabsorbed, with only a small amount excreted.
Main wavelength:
Its increase is commonly found in renal inadequacy caused by various nephropathies, such as glomerular injury in the Sample consumption: 2μL 600nm
early stage, primary glomerulonephritis, interstitial nephritis, diabetic nephropathy, lupus nephritis, acute and chronic R1 consumption: 240μL Detection temperature:
37℃
renal failure, and so on; also found in IgA myeloma, liver cancer, etc. Its decrease means severe liver function damage,
seen in patients with liver disease. Add R2：60μL Record absorbance A2
 Principle
Record absorbance A1
The reagent uses the latex enhanced immune turbidity method. Anti human α1-MG antibody is combined with latex
particles by chemical crosslinking. When a sample contains the corresponding antigen, they are combined with
300s 24s 276s
latex-antibody particles to form the antigen-antibody-latex particle compounds. The turbidity increases with the antigen
content; through the comparison with the turbidity of a series of calibrators can be calculated the antigen content in the
sample.
4. Calibration
 Main Components It’s recommended to use the matching calibrator to execute multi-point calibration. After the detection, automatic fitting
Reagent Kit Main Components Concentration/Content of calibration curves will be done by the instrument. In the case of reagent lot number change or QC out of control,
calibration should be done again.
Reagent 1（R1） Phosphate buffer 20mmol/L
5. QC
Latex solution combined with anti-human It’s advised to use the control products made by DIRUI for quality control. The lab shall establish control ranges and
Reagent 2（R2） ＞0.2%
α1-microglobulin antibody limited values by itself, if control values are out of control, proper measures shall be taken.
6. Detection result calculation
α1-MICROGLUOBULIN Calibration Sample See the label According to the calibrator concentration and the corresponding absorbance change value △A, a nonlinear function is
Note: Each component of the reagent kits with different lot numbers is not interchangeable. used to determine the calibration curve; the measured concentration is the concentration value corresponding to the
sample absorbance change on the calibration curve.  Reference
 Reference Range 1. Lin Qisui, etc. Clinical Chemistry Test. Peking University Press, 1990: first edition: 4
10mg/L—30mg/L 2. Chironna et al. Int JClin Lab Rws 1994: 24: 90-93.
The reference range is only for reference. It’s recommended that each laboratory consider the applicability of the 3. National Clinical Laboratory Operation Procedures, third edition.
reference values to the exposed population group, and define a reference range by itself if necessary. 4. Wibell L et al. Nephron 1973; 10 320-331.
 Detection Results Explanation 5. NCCLS. Interference Testing in Clinical Chemistry; Approved Guideline, 2005.

1. If the reaction temperature is 25℃ or 30℃, the incubation time is extended to 8 minutes or 6 minutes  Specifications Approval Date and Modification Date:11/2018
correspondingly.
2. In a sample, if the content of α1-MG is more than 100mg/L, the sample should be diluted to 100mg/L for the
determination; the result is to be multiplied by the dilution times.
3. Detection of α1-MG concentration is only one of the indexes for clinicians to diagnose patients’ disease. Clinicians
need to make a comprehensive judgment according to patients’ symptoms, medical history, and other diagnostic items
and methods.
 Limitations of Detecting Method
1. The accuracy of the test results depends on the instrument calibration, test temperature, and time control.
2. In a sample, when Jaundice＞300μmol/L, hemoglobin＞4.0g/L, triglyceride＞10mmol/L, ascorbic acid＞1.7mmol/L,
rheumatoid factor≥240IU/mL, test results may be affected.
3. When the content of α1-MG is more than 100mg/L, the sample needs diluting and then detecting again.
 Product Performance Index
1. Reagent blank absorbance: A≤2.500.
2. Analysis sensitivity: when testing 50mg/L analyte, absorbance change ΔA≥0.020.
3. Linear range: 2mg/L—100mg/L; linear correlation coefficient r≥0.990; when linear range is 2mg/L—40mg/L
（including 40mg/L）, absolute deviation should not exceed ±6mg/L; when linear range is 40mg/L—100mg/L,
relative deviation should not exceed±15％.
4. Accuracy:
80%≤rate of recovery≤120%.
5. Measurement precision:
Repeatability: CV≤8%.
Between-run difference: R≤10%.
 Matters Needing Attention
1. Matters needing attention regarding use
1.1 The product is only used for in vitro diagnosis.
1.2 Avoid adding reagents during testing.
1.3 According to the requirements of different instruments, the dosage of reagent and sample can be changed
proportionally.
1.4 The reagent cannot be frozen.
2. Matters needing attention regarding safety
2.1 Please dispose of the sample as hazardous materials possibly infected with HIV, HCV, HBV, etc. To avoid or reduce
the risk of infection, use disposable gloves.
2.2 The reagent is toxic and corrosive; if it comes into contact with the eyes, mouth, or skin, immediately wash with water;
if necessary, please go to see a doctor.
2.3 Samples, waste liquid, etc. are potentially infectious, so the operator should comply with laboratory safety operation
regulations, and dispose of them according to the local medical waste, infectious waste, industrial waste and other
treatment regulations.