Selling unit: per 100ml
Common name: Anti-streptococcal hemolysin O (ASO) assay kit (latex-enhanced immunoturbidimetric method)
English name: ASO Reagent Kit (Immuno- turbidimetric Method)
3:1, 4:1, 5:1, common ratio 4:1, other ratios need to be customized
This kit is used to determine the viability of ASO in human serum.
The body can produce anti-streptococcal hemolysin “O” antibodies after being infected by streptococci, ASO this antibody is the exotoxin of streptococci. Testing for ASO can help diagnose diseases caused by Streptococcus haemolyticus such as rheumatoid, acute glomerular disease, scarlet fever and tonsillitis.
Streptococcal hemolysin O is encapsulated on latex particles, which can produce agglutination reaction with ASO in serum and form antigen-antibody complexes, whose turbidity is proportional to ASO in serum when a certain amount of antibody is present. The amount of ASO in serum can be calculated by measuring the absorbance value at a specific wavelength and referring to the multi-point calibration standard curve.
Reagent components included in the product.
* The components of the kits are not interchangeable between batches.
*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.
Storage Conditions And Expiration Date
The kit is stored at 2-8°C away from light and is valid for one year.
Reagents that have been opened are careful not to be contaminated, and reagents are stable in the instrument compartment (2-8°C) for one month.
The reagents must not be frozen.
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
Fresh serum, which should be separated within 2 hours after blood collection, can be stored at room temperature (15-25°C) for 2 days, 2-8°C for 2 days, and -20°C for 6 months.
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- test conditions: (different parameters on the machine can be requested according to different testing instruments)
Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.
- Calibration procedure.
Landau calibrators are recommended.
- QC control procedures.
It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
5 points are calibrated and the corresponding values are entered. Plot the standard curve with △A as vertical coordinate and concentration as horizontal coordinate, and correct this standard curve with suitable mathematical model such as Logit-Log4P, Spline model, and save this standard curve for calculating the results. The reagents of different batches must be re-calibrated.
Positive Judgment Value Or Reference Interval
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation Of Test Results
The ASO measurement in serum is only one of the indicators used by the clinician to diagnose the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and tools.
Limitations Of The Test Method
Bilirubin ≤ 40 mg/dL, hemoglobin ≤ 500 mg/dL and celiac ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 604 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 1.0.
Analytical sensitivity: the kit tests 100 IU/ml of the analyte, the absorbance change value ΔA ≥ 0.03.
Linearity range: reagent linearity in the interval of 20~800 IU/ml, linear correlation coefficient: r ≥ 0.975; in the interval of 20~200 IU/ml, the absolute deviation of linearity should not exceed 20 IU/ml; in the interval of (200~800 IU/ml, the relative deviation of linearity should not exceed ±10%.
Precision: repeatability CV≤ 6.0%; relative extreme difference between batches≤ 10.0%.
Accuracy: Relative deviation ≤ 10%.
- This product is for in vitro diagnosis only.
- Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
- Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
- Do not mix R1 and R2 into a single reagent, or exchange reagents with different lot numbers.
- When changing the reagent lot number, please recalibrate.
- The latex reagent (R2) itself has a certain turbidity, and its particle diameter is 100 nm-200 nm, the trace has strong Brownian motion in the solution, so the reagent does not need to be shaken well before use.
- Colorimetric liposome lysis for assay of anti-streptolysin O antibody; Clin. Chem., Oct (1990); 36: 1747-1749