1 x 53/1 x 20 mL

ASO 12011027

Intended Use Reagents required but not provided

This reagent is intended for in vitro quantitative determination of Anti Streptolysin Agappe ASO Calibrator (Product Code: 11615003)
– O (ASO). Agappe Protein Control (Bi-Level) (Product Code: 11614007)
-Latex enhanced immunoturbidimetry
-Linear up to 800 IU/mL Calibration
Agappe ASO Calibrator( Product Code:11615003) is recommended for calibration
Clinical Significance of the assay.
β-hemolytic streptococcus bacteria especial ly group A, C and G, produce an
exotoxin known as Streptolysin-O. People infected with this bacterium produce Quality Control
an antibody known as Anti Streptolysin-O (ASO). Measuring the levels of ASO is It is recommended to use Agappe Protein Control (Bi-Level) (Product Code:
effective for diagnosing, judging the progress of medical treatment and assessing 11614007) to verify the performance of the assay.
the recovery from diseases like rheumatic fever, acute glomerulonephritis and Each Laboratory has to establish its own internal quality control scheme and
tonsillitis. procedures for corrective action if controls do not recover within the acceptable
tolerance.
Principle
When an antigen-antibody reaction occurs between ASO in the sample and Reference Range
streptolysin-O which has been sensitized to latex particles, agglutination occurs. It is recommended that each laboratory should establish its own reference values.
This agglutination results in change of absorbance and is proportional to the The fol lowing value may be used as guide line.
quantity of ASO in the sample. The actual concentration is determined by Adults : Up to 200 IU/mL
interpolation from a calibration curve prepared from calibrators of known Children <5years : Up to 100 IU/mL
concentration. Results obtained for patient samples are to be correlated with clinical findings of
patient for interpretation and diagnosis.
Kit Components
Reagent/ Product Code Description Performance
Component 12011027 1. Linearity
ASO R1 1 x 53 mL Glycine Buffer Solution The reagent is linear up to 800 IU/mL. If the concentration is greater than linearity
(800 IU/mL), dilute the sample with normal saline and repeat the assay. Multiply
the result with dilution factor.
ASO R2 1 x 20 mL ASO Latex suspension particles coated with
Streptolysin - O 2. Comparison
A comparison study has been performed between Agappe reagent and another
Risk & Safety internationally available reagent yielded a correlation coefficient of r 2= 0.999 and
Material Safety data sheets (MSDS) wil l be provided on request a regression equation of y = 0.9939x.
Reagent Preparation 3. Precision
ASO R1 & R2 Reagents are ready to use. Intra Run Inter Run
Reagent Storage and Stability Control Level 1 Level 3 Level 1 Level 3
The sealed reagents are stable upto the expiry date stated on the label, when stored n 20 20 20 20
at 2-8OC. Mean (IU/mL) 53.01 223.56 54.74 221.77
SD 2.10 3.87 2.10 4.21
Open Vial Stabil ity
Once opened the reagents are stable up to 90 days if contamination is avoided. CV(%) 3.96 1.73 3.84 1.9

On-board Calibration Stabil ity

Calibration is stable for 20 days. Accuracy (IU/mL)
Control Expected Value Measured Value
Reagent Deterioration
Control Level 1 49 ± 10.6 52.41
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range Control Level 3 100 ± 19.1 105.98
for the Agappe Protein Control may also be an indication of reagent instability Agappe Control Level 1 155.8 ± 21 153
and associated results are invalid. Sample should be retested using fresh vial of
reagent.
4. Sensitivity
Precaution Lower detection Limit is 20 IU/mL
To avoid contamination, use clean laboratory wares. Close reagent bottles Bibliography
immediately after use. Avoid direct exposure of reagent to light. Do not blow into
1. Galuin, J.P. et al.: Particle enhanced photometric immune assay system, Clin.
the reagent bottles.
Lab Assays (pap .Annu.clin.Lab.Assays Conf.)
This reagent is only for IVD use and fol low the normal precautions required for
hand ling al l laboratory reagents. 2. Singer J.M. et al. The latex fixation test Application to the serologic diagnosis
Waste Management or rheumatoid arthritis ,AmerJ.Med 21, 888(1956)
Reagents must be d isposed off in accordance with local regulations.
Sample
Fresh serum/plasma. Do not use lipemic or hemolysed sample
Interferences
No interference for
Bilirubin up to 20 mg/dL
Haemoglobin up to 500 mg/dL
Intrafat up to 5000 mg/dL

Materials provided
ASO R1 & R2 Reagent

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001:2015
customersupport@agappe.in | www.agappe.com REV. NO.: ADL/IFU/ASO/120FR/R02 EN ISO 13485:2016