|
|
| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
LYME SEROLOGY PANEL(WH)
MessageSENDOUT/WEST HAVEN CT
Test Code
LYME SEROLOGY PANEL(WH)
Includes
LYME AB,FINAL INTERPRETATION(wh), TIER 1 LYME SCREENING EIA(wh), TIER 2 LYME EIA,IgG(wh), TIER 2 LYME EIA,IgM(wh)
Preferred Specimen
SERUM
Minimum Volume
3mLs
Instructions
DRAW 1 GOLD TOP SST TUBE, LET CLOT FOR 30 MINUTES, SPIN DOWN AND SEND TO LAB.
Transport Container
ORIGINAL TUBE
Transport Temperature
REFRIGERATED
Methodology
ZEUS SCIENTIFIC EIA-MTTT-IVD
Setup Schedule
2 OR MORE RUNS/WEEK, VARIABLE
Report Available
3-8 DAYS
Reference Range
NEGATIVE
Clinical Significance
VA CT Molecular Diagnostics Laboratory announces a methodology change for Lyme antibody testing to the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. This enzyme immunoassay (EIA) is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease.
Specimens with positive or equivocal test results will undergo supplemental testing using a Modified Two-Tier Test (MTTT) approach. This modified methodology uses supplemental EIAs in place of western immunoblot assays. The FDA has determined that MTTT is “substantially equivalent to or better than” STTT and meets CDC guidelines for Lyme disease testing. Second tier testing at VA CT will utilize the ZEUS ELISA B. burgdorferi IgM Test System and the ZEUS ELISA B. burgdorferi IgG Test System. In a VA CT verification study, the MTTT and STTT showed 100% agreement in a comparison of 50 positive and 74 negative samples.
Positive or equivocal test results in the first “tier” screening EIA (which detects both IgG and IgM) plus a positive result on either or both of the second tier EIAs (which each detect either IgG or IgM) constitute an overall positive result. A positive result is supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the cause of Lyme disease, but should not be used as a sole criterion for diagnosis. The diagnosis of Lyme disease must also be based on the patient’s exposure history, signs/symptoms, and other laboratory data.
Specimens with positive or equivocal test results will undergo supplemental testing using a Modified Two-Tier Test (MTTT) approach. This modified methodology uses supplemental EIAs in place of western immunoblot assays. The FDA has determined that MTTT is “substantially equivalent to or better than” STTT and meets CDC guidelines for Lyme disease testing. Second tier testing at VA CT will utilize the ZEUS ELISA B. burgdorferi IgM Test System and the ZEUS ELISA B. burgdorferi IgG Test System. In a VA CT verification study, the MTTT and STTT showed 100% agreement in a comparison of 50 positive and 74 negative samples.
Positive or equivocal test results in the first “tier” screening EIA (which detects both IgG and IgM) plus a positive result on either or both of the second tier EIAs (which each detect either IgG or IgM) constitute an overall positive result. A positive result is supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the cause of Lyme disease, but should not be used as a sole criterion for diagnosis. The diagnosis of Lyme disease must also be based on the patient’s exposure history, signs/symptoms, and other laboratory data.
Performing Laboratory
Molecular Diagnostics Laboratory PERFORMING LAB: WEST HAVEN PHONE #: 203-932-5711 EXT: 2915/3556 FAX: 203-937-4786
