Description

The Diagnostic Automation, Inc. Borrelia burgdorferi ELISA kit is designed to detect IgM and IgG class antibodies to Borrelia burgdorferi in human sera. Wells of plastic microwell strips are sensitized by passive absorption with Borrelia burgdorferi antigen. The test procedure involves three incubation steps:
1. Test sera (properly diluted) are incubated in antigen coated microwells. Any antigen specific antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.
2. Peroxidase Conjugated goat anti-human IgM/IgG is added to the wells and the plate is
Incubated The Conjugate will react with IgM and/or IgG antibody immobilized on the solid phase in step 1. The wells are washed to remove unreacted Conjugate.
3. The microwells containing immobilized peroxidase Conjugate are incubated with peroxidase Substrate Solution. Hydrolysis of the Substrate by peroxidase produces a color change. After a period of time the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends upon the antibody concentration in the original test sample.

Normal precautions exercised in handling laboratory reagents should be followed. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing, gloves, and eye/face protection. Do not breathe vapor. Dispose of waste observing all local, state, and federal laws.

The wells of the ELISA plate do not contain viable organisms. However, the strips should be considered POTENTIALLY BIOHAZARDOUS MATERIALS and handled accordingly.

The human serum controls are POTENTIALLY BIOHAZARDOUS MATERIALS. Source materials from which these products were derived were found negative for HIV-1 antigen, HBsAg. and for antibodies against HCV and HIV by approved test methods. However, since no test method can offer complete assurance that infectious agents are absent, these products should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health manual “Biosafety in Microbiological and Biomedical Laboratories”: current edition; and OSHA’s Standard for Bloodborne Pathogens.

The performance characteristics of the DAI B. burgdorferi ELISA kit is not established with samples from individuals vaccinated with B. burgdorferi antigens. Screening of the general population should not be performed. The positive predictive value depends on the pretest likelihood of infection. Testing should only be performed when clinical symptoms are present or exposure is suspected.