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The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (FA) test procedure for B. burgdorferi antibodies.

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit also includes Blot Reading Guides, report forms and a Package Insert.

The BBI-Biotech B. burgdorferi IgM Western blot kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

The device is a collection of cGMP manufactured critical components needed to perform a Western blot test that will detect B. burgdorferi IgM antibody in naturally infected humans. It includes nitrocellulose strips upon which sodium dodecyl sulfate solubilized and polyacrylamide separated B. burgdorferi proteins have been transferred, an IgM Positive Control, a Negative Control, an anti-IgM alkaline phosphatase concentrate, a buffer concentrate, diluent powder, an NBT/BCIP substrate, Blot Reading Guide, Package Insert, and Results Record Forms.

ACCURUN™ 150 HSV IgG Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to herpes simplex virus (HSV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 150 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product is not FDA cleared for use in testing blood or plasma donors. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to HSV in human serum.

ACCURUN™ 150 HSV IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 150 and all human blood. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to HSV in human serum. This control is supplied as 1 x 1 ml vial and 1 x 5 ml vial. ACCURUN™ 150 should be stored at 2-8°C. Once opened, ACCURUN™ 150 should be discarded after 60 days.

ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 130 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. Boston Biomedica intends to manufacture and market ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control, which is a human blood based single analyte unassayed run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. This product is not FDA cleared for use in testing blood or plasma donors. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Borrelia burgdorferi in human serum.

ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Borrelia burgdorferi, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 130 and all human blood. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Borrelia burgdorferi in human serum. This control is supplied as 1 x 1 ml vial. ACCURUN™ 130 should be stored at 2-8°C. Once opened. ACCURUN™ 130 should be discarded after 60 days.

ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 132 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product is not FDA cleared for use in testing blood or plasma donors.

ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to Borrelia burgdorferi, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 132 and all human blood. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum. This control is supplied as 1 x 1 ml vial. ACCURUN™ 132 should be stored at -10°C or colder. Once opened, ACCURUN™ 132 should be stored at 2-8°C and discarded after 60 days.

ACCURUN™ 135 Toxoplasma IgG Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 135 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product is not FDA cleared for use in testing blood or plasma donors. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Taxoplasma gondii in human serum.

ACCURUN™ 135 Toxoplasma IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Toxoplasma gondii, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 135 and all human blood. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Toxoplasma gondii in human serum and plasma. This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 135 should be stored at 2-8°C. Once opened, ACCURUN™ 135 should be discarded after 60 days.

ACCURUN™ 140 Rubella IgG Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Rubella virus. This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 140 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Rubella virus in human serum and plasma.

ACCURUN™ 140 Rubella IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Rubella, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 140 and all human blood. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Rubella virus in human serum and plasma. This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 140 should be stored at 2-8°C. Once opened, ACCURUN™ 140 should be discarded after 60 days.

ACCURUN™ 146 CMV IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 146 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to CMV in human serum and plasma.

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin™ as preservative. This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.

Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits. This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in virro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.

human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV).

ACCURUN 117 HBeAg Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits. ACCURUN 117 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

ACCURUN 117 HBeAg Positive Control is a human blood based single analyte run control.