Sample
Human serum or plasma
Intended Use
Enzyme immunoassay for the qualitative and quantitative determination of IgG antibodies against cardiolipin in human serum or plasma (EDTA, citrate, heparin).
Contents of Kit
1.Microtiter Plate
2.Enzyme Conjugate IgG
3.Calibrator A-F
4.Negative and Positive Contro
5. Sample Diluent
6.TMB Substrate Solution
7.Wash Buffer
8.TMB Stop Solution
9. Directions for use.
10.Lot-specific certificate of analysis
Storage
Store kit at 2 - 8°C. It is stable up to the expiry date stated on the label of the box. Do not use kit beyond its expiry date.
Detection Range
2 - 100 GPL-U CL/β2-GP1 IgG per mL sample
Detection Limit
The detection limit is defined as that concentration of analyte that corresponds to the mean absorbance of Sample Diluent plus 3-fold standard deviation (s). It was determined as < 0.5 GPL-U CL/β2-GP1 IgG per mL sample
Sensitivity
It was determined as < 0.5 GPL-U CL/β2-GP1 IgG per mL sample
General Description
The present enzyme-linked immuno sorbent assay (ELISA) is intended for the quantitative or qualitative determination of IgG antibodies directed against CL/β2-GP1 in human serum or plasma.
Standard Curve
The depicted curve can only serve as a model. It can not substitute the measurement of the calibrators, together with the controls and actual samples.

Citations
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