Specification
IN15 Insulin Test is a rapid quantitative reader for the detection of insulin in whole blood assay samples. The method is based on an unique combination of monoclonal dye conjugate and polyclonal solid phase antibodies to identify insulin in the test samples with a high degree of specificity.
Storage and Stability
AIl IN15 kit components should be stored between +4°C and +30°C.
Do not freeze the test kit, IN15 is stable until the expiry date stated on the package
Precautions
For in vitro diagnostic use and for professional use only.
Read the User Guide carefully before using the test.
Handle all specimens as if they contained infectious agents.
When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour.
Alternatively, they can be treated with 0.5% to 1% solution of sodium hypochlorite for one hour before disposal.
Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.
Do not eat, drink or smoke in the area where specimens and kit reagents are handled.
Avoid any contact between hands and eyes or nose during specimen collection and testing.
Do not use the test from a damaged protective wrapper.
Do, not use beyond the expiry date which appears on the package label.
Performance
Linearity
The measuring range is 1 -
For Insulin concentration below 1 µIU/mL, the result will be given as "< 1 µIU/mL.".
For Insulin concentration over
For samples whose concentration is higher than 400 µIU/mL, dilute with saline and repeat the assay as User Guide.
Accuracy
A study has been performed using serum samples obtained from dilutions of Insulin international reference material WHO (83/500) covering a range of 1 to
Y = 42.28 + 5.74 x - 1.5.10-3 x2 (r = 0.967)
The results show a good correlation (r = 0.967) of the values obtained with IN15 Pro Cassettes on IN15 Pro readers.
Sensitivity
Concentrations close to 1 µIU/mL are detected by IN15 Pro (model 1) test. In these cases, results will be rendered as
"< 1 µIU/mL". Levels over 20 µIU/mL. are considered as abnormal.
Precision
A correlation study was performed on 50 known serum samples preassaved on Beckman Dxi analyser. The results show an overal. correlation of 99.2 % between
Hook effect
There was no observed hook effect up to an insulin concentration of 9,335 pIU/mL.
Intra assay reproducibility
Within run reproducibility was evaluated using 25 replicates of three sera containing 17.8, 53.6 and 132.3 µIU/mL of insulin. The obtained CV (coefficient of variation) are 11.7%, 12.4% and 12.7 % respectively.
Inter assay reproducibility
Between lots reproducibility was determined by using three specimens containing 3.6; 2.0 and 5.1 µIU/mL of Insulin, tested in 3 independent assays with three different lots of reaction device.
The obtained coefficients of variation (CV) were respectively 14.5%; 12.8% and 11.7%.
Limits