BD™ Cytometric Bead Array (CBA) Human IgG2 Flex Set

The BD CBA Human IgG2 Flex Set must be used in conjunction with a BD CBA Human Immunoglobulin Master Buffer Kit (Cat. No. 558683, 100 tests), a flow cytometer, and the FCAP Array™ Software (Cat. No. 641488). Detailed instructions on the use of this product can be found in the manual for the BD CBA Human Immunoglobulin Master Buffer Kit. When following the directions in the Master Buffer Kit, the top standard point for the BD CBA Human IgG2 Flex Set will be 3,400 ng/ml. An example standard curve is shown in Figure 1. The Human Ig Standard provided in this Flex Set is derived from human serum and contains Human IgG1, IgG2, IgG3, IgG4, IgM, IgA and IgE proteins. Only one Human Ig Standard vial is needed when preparing standard curves for a multiplex assay using multiple Human Immunoglobulin Flex Set assays. The BD CBA Human IgG2 Flex Set cannot be used in the same assay well with the following BD CBA Immunoglobulin Flex Set reagents:

Flex Set                                                        Bead Position          Catalog Number

BD CBA Human IgG1 Flex Set                             C4                              558675

BD CBA Human Total IgG Flex Set                     C6                              558679

Due to the levels of immunoglobulin protein in typical samples and specific assay conditions, the BD CBA Human IgG2 Flex Set should not be used in the same assay well with any non-BD CBA Human Immunoglobulin Flex Set reagents (such as BD CBA Mouse Soluble Protein, Human Soluble Protein or Cell Signaling Flex Sets). For an updated assay compatibility chart for the BD CBA Human Immunoglobulin Flex Sets, please refer to the BD CBA Flex Set System homepage at http://www.bdbiosciences.com/flexset.

Performance

Limit of Detection: The theoretical limit of detection is 0.85 ng/ml and was determined by evaluating the estimated result of the average MFI of the negative control (0 pg/ml, n=30) + 2 standard deviations.

1. Source of all serum proteins is from USDA inspected abattoirs located in the United States.
2. ProClin is a trademark of Rohm and Haas Company.
3. This product contains human blood, serum, cells, or materials derived from them, which are potentially hazardous materials. Use universal precautions when handling. Handle as if product were capable of transmitting disease. Material used in this product has been tested using FDA approved methods and found negative for Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Surface Antigen (HBSAG) and antibody to Hepatitis C Virus (HCV). However, no known test method can offer complete assurance that specimens of human origin will not transmit infectious disease. When handling or disposing, follow precautions described in CDC and FDA recommendations and OSHA Bloodborne Pathogen recommendations.
4. Caution: Sodium azide yields highly toxic hydrazoic acid under acidic conditions. Dilute azide compounds in running water before discarding to avoid accumulation of potentially explosive deposits in plumbing.
5. Warning: CBA lyophilized standard contains 0.02% (w/w) of a CMIT/MIT mixture (3:1), which is a mixture of:5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC No 220-239-6] (3:1).Hazard statement: May cause an allergic skin reaction.Precautionary statements: Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/eye/face protection. Wear protective clothing. Avoid breathing mist/vapours/spray. If skin irritation or rash occurs: Get medical advice/attention. IF ON SKIN: Wash with plenty of water. Take off contaminated clothing and wash it before reuse. Dispose of contents/container in accordance with local/regional/national/international regulations.