2 x 50 Test

Insulin CLIA 52025097

Intended Use This product does not involve human source substances and has no biosafety hazard,
Insulin (CLIA) is intended for in-vitro quantitative measurement of Insulin (INS) but it should still be considered as a potential infectious substance. The treatment,
in human serum or plasma by chemiluminescent immunoassay. use, storage of each component and the disposal of solid and liquid wastes
generated in the analysis process should be hand led in accordance with the
Clinical Significance corresponding measures of local biosafety guidelines or regulations.
Insulin (INS) is a protein hormone synthesized, stored, and secreted by the All test equipment and related glass and plastic wares should be clean and free of
pancreatic â cells. It consists of two peptide chains A and B, and contains a total of contaminants.
51 amino acid residues. The biosynthesis rate of INS is affected by blood glucose
concentration. When blood glucose concentration increases, INS synthesis is Packaging materials that are non-degradation should be collected and delivered
accelerated. INS is the unique hormone in human body that can lower the blood to the local process center.
glucose and promote the synthesis of glycogen, fat and protein. It is the main
purpose for INS detection that to understand patient’s pancreatic functional status, Do not use reagent kits beyond the expiration date.
to analyze the cause of diabetes, to monitor the stage of disease, and to observe
the patient’s response to treatment, etc. At present, methods commonly used for
Waste Management
INS detection are chemiluminescent immunoassay and enzyme-linked Reagents must be disposed o in accordance with local regulations
immunoassay.
Sample
Principle Serum/Plasma
Specimen Col lection&Storage
This insulin assay is a “sandwich” chemiluminescent magnetic microparticle
Follow this package insert as well as the specimen collection tube manufacturer’s
immunoassay. Immunomagnetic microparticles (IMMP), specimen and the
instructions for specimen collection and preparation. Raw materials and addictive
acridinium ester (AE) labelled conjugate are mixed and incubated to form “IMMP-
may vary among different manufactures’ collection tubes, which may result in
INS-conjugate” complexes. After washing, the excess conjugate and other
different results. This kit has not been tested with all collection tube manufactures.
substances are removed, and then the Chemiluminescence Analyzer Substrate
Each laboratory needs to determine the feasibility of the collection tubes or serum
Buffer is added, the resulting chemiluminescent reaction is quantified in relative
separation products. The specimens should be free of microbial contamination,
light unit (RLU). The value of RLU is directly proportional to the concentrations of
fibrin, cells or other particulate matter, severe lipemia, severe hemolysis. If the
INS in the specimen.
sample is cloudy or has visible flocculent, the sample shall be centrifuged, and the
Kit Components supernatant can be used for detection.
If testing cannot be done before 24 hours after blood collection, the specimens
Reagent Product Code Description shall be separated to serum or plasma and then be stored. Specimens may be stored
52025097 for up to 24 hours at 2°C~8°C or 3 months at -20°C. Multiple freeze-thaw cycles of
Insulin R1 3.5 mL Magnetic microparticles coated with anti- specimens should be avoided. The sample should be transported at low
temperature.
human Insulin monoclonal antibody
Ensure the patients’ samples, calibrators and controls are at ambient temperature
Insulin R2 6 mL Acridinium ester labelled anti-human (15°C~25°C) before measurement.
Insulin monoclonal antibody
Do not use mixed specimens.
Insulin R3 3.5 mL Phosphate bufAssay Buffer with Tris 0.1 mol/L
Volume required: 200 µL for the first Insulin test plus 50 µL for each additional
Calibrator-1 1 mL Recombinant insulin antigen Insulin test from the same sample tube.
Calibrator-2 1 mL Recombinant insulin antigen Materials provided
Plastic Opener 2 nos Insulin Casette,Calibrator & Plastic Opener
Procedure
* Note: Do not mix or interchange d ifferent batches of kit. Follow the procedures described in Automatic Chemiluminescence Analyzer User
Manual.
Risk & Safety
Verify that test parameters are loaded before reagents are loaded, for specific
Material Safety data sheets (MSDS) will be provided on request operations, please refer to the analyzer user manual.
Reagent Storage and Stability Check the integrity of the kit before use. Do not use if damage or leakage found.
The unopened reagents and calibrators are stable until the expiration dates stated
on the labels, when stored upright at 2-8OC and protected from direct sunlight. Prior to running the kit, ensure that the magnetic microparticles are mixed to keep
Avoid freezing. After opening, the reagents are stable for 35 days when used on them suspended and avoid formation of foam.
board, and the calibrators are stable for 35 days at 2-8OC.
Place the reagents in the reagent compartment. When the reagent compartment is
Open Vial Stability closed, the analyzer will automatically scan and read the reagent RFID information.

Once opened, the reagent casette is stable up to 35 days when kept at 2-8 OC. Cal ibration
Ensure the calibrator to ambient temperature, mix and place it on the calibrator
On-board Calibration Stability rack.
Calibration is stable for 7 days.
Make sure that the reagent and calibrator lot are same before loading.
Precaution
Place the reagent kit in upright position always. Ensure the related calibrator information is obtained by the analyzer, for specific
operations, please refer to the analyzer user manual.
For in vitro diagnostic use only.
Recommended calibration frequency:
Package insert must be followed accordingly. Reliability of assay results cannot be For every new reagent lot.
guaranteed if there are any deviations from the instructions in this package insert.
The controls are out of range.
This product requires the handling of human specimens. It is recommended that
all human sourced materials be considered potentially infectious and handled in After 35 days when using the same reagent lot.
accordance with applicable laws. Al l materials contaminated with patient
After 7 days when using the same reagent kit.
specimens should be inactivated by validated procedures (autoclaving or chemical
treatment) in accordance with applicable regulations. After major repair or replacing spare parts
This product contains chemical ingredients. Contacting with skin or mucosa should
be avoided. If the product is spilled into eyes, mouth or skin accidentally, rinse
with running water and seek for doctor advice if necessary.

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ISO 9001:2015
www.agappe.com EN ISO 13485:2016
Rev.0.280622
 Insulin CLIA 2 x 50 Test
52025097

Quality control
Ensure the control to ambient temperature, mix and place it on the required rack.
Performance
Ensure the related control information is obtained by the analyzer for specific 1.Accuracy:
operations, please refer to the analyzer user manual.
The recovery rate is within the range of 85.0%~115.0%.
Ensure that control values are within the concentration ranges.
2.Sensitivity:
Recommended quality control frequency:
For every new reagent. Limit of blank is  1 mIU/L The limit of blank is the 95th percentile value of the
zero-concentration calibrator for repeated determination.
After every calibration.
Limit of detection is 2 mIU/L.
Once every 24 hours when the test is in use.
The limit of detection is the lowest analytical concentration which is distinguished
If the quality control procedures in user’s laboratory require more frequent use of from the limit of blank (Miscalculation probability  = 0.05).
controls to verify test results, follow the laboratory specific procedures.
Limit of quantification is 3 mIU/L.
Limitation
3.Linearity:
This assay has only been validated for the specimen type of human serum and
plasma (heparin and EDTA). Other types of specimens have not been validated. In the range of 1.00 mIU/L~500.00 mIU/L, the coefficient of correlation r is not less
than 0.9900.
Specimens of severe icterus, hemolysis, lipemia and contamination may result in
error results. 4.Precision:
Interference due to extremely high titers of antibodies to streptavidin and intake The intra-lot coefficient of variation (CV) is not higher than 8.0%.
of high dose of biotin can occur.
The inter-lot coefficient of variation (CV) is not higher than 15.0%.
Heterophilic antibodies in specimen can react with reagent immunoglobulins,
interfering with in vitro immunoassays. 5. Interference

Patients routinely exposed to animals or animal serum products can be prone to Interfering Substance Concentration (Max)
this interference and anomalous values may be observed.
Hemoglobin  2.0 g/L
The results of different detection systems cannot be used interactively.
Triglycerides  9.0 mmol/L
Reference Range Bilirubin  400 µmol/L
2.00 mIU/L ~ 20.00 mIU/L Biotin  20 ng/mL
The above reference interval is the central 95% interval of the measurement results RF factor  3000 IU/mL
of 124 specimens from fasting normal population. It is recommended that each
laboratory establish its own normal range which may be unique to the population 6.HOOK TEST:
it serves depending upon ethnics, geographical, patient, dietary, or environmental There is no high-dose hook effect at INS concentrations up to 20,000 mIU/L.
factors.
7.SPECIFICITY
Interpretation of Result When the concentration of proinsulin is not lower than 10 ng/mL, the measured
The test results shall be only considered as a clinical reference rather than the result of INS is not higher than 3.00 mIU/L; When the concentration of C-peptide
unique basis for confirming or excluding a case. For diagnostic purposes, results is not lower than 20 ng/mL, the measured result of INS is not higher than 3.00
should always be used in combination with clinical examination, medical history mIU/L.
and other result of inspection. BIBLIOGRAPHY
1. Sapin R. Insulin Assays : Previously Known and New Analytical Features. Clin
Lab. 2003, 49(3-4): 113-121.
2. Clark PM. Assays for insulin, proinsulin(s) and C-peptide. Ann Clin Biochem
1999, 36(5): 541-564.

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ISO 9001:2015
www.agappe.com EN ISO 13485:2016

Rev.0.280622