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The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant. The Premier Resolution System is intended for Professional Laboratory Use only. The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech. The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).

Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

The kit is an immunoblot method to detect IgM antibodies against B. burqdorferi antigens. The test kit contains: . Nitrocellulose Test Strips with purified B. burgdorferi antigens (3) and quality control lines (3) present in specific positions . Sample Diluent. Provided for specimen dilutions. Contains BSA and PBS Positive Control derived from human serum positive for Lyme disease. Contains <0.1% sodium azide Negative Control derived from human serum negative for Lyme disease. Contains <0.1% sodium azide Conjugate. Antihuman IgM-HRP Conjugate binds reactive antibodies to the Substrate TMB Substrate. Provides colorimetric reaction for visual read of bound antibodies PBS Wash Buffer concentrate. Removes reagents and unbound antibodies after incubation steps. Must be reconstituted to 1L with distilled or deionized water. To perform the test, serum or plasma is individual B. burgdorferi Test Strips. In positive sera antibodies specifically bind to one or more of the test lines on the strips are washed according to the protocol, and then the pre-diluted, ready-to-use Conjugate is added to the test strips. After incubation and wash steps, the ready-to-use Substrate is added to the strips. During a 10 minute (±4 min) incubation, conjugate and substrate binding produces visible blue/purple lines for Serum Addition Control (SAC), Conjugate Addition Control (CAC) and Cut-Off Control lines. If the sample is positive for any of the antigen coated test lines, it will show a reaction more intense than the Cut-Off line. Reactions are read visually and reported as positive or equivocal (comparable to Cut-Off line). Strips which have 2 (or more) of the 3 test lines are considered positive for specific IgM antibody to B. buradorferi.

Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2- EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

The kit is an immunoblot method to detect IgG antibodies against B. burqdorferi antigens. The test kit contains: Nitrocellulose Test Strips with purified B. burgdorferi antigens (10) and quality control lines (3) present in specific positions, Sample Diluent, Positive Control, Negative Control, Conjugate (Antihuman IgG-HRP Conjugate), TMB Substrate, and PBS Wash Buffer concentrate. To perform the test, serum or plasma is added to individual B. burgdorferi Test Strips. In positive sera antibodies specifically bind to one or more of the test lines on the strips are washed according to the protocol, and then the pre-diuted, ready-to-use Conjugate is added to the test strips. After incubation and wash steps, the ready-to-use Substrate is added to the strips. During a 10 minute (±4 min) incubation, conjugate and substrate binding produces visible blue/purple lines for Serum Addition Control (SAC), Conjugate Addition Control (CAC) and Cut-Off Control lines. If the sample is positive for any of the antigen coated test lines, it will show a reaction more intense than the Cut-Off line. Reactions are read visually and reported as positive or equivocal (comparable to Cut-Off line). Strips which have 5 (or more) of the 10 test lines are considered positive for specific IgG antibody to B. burgdorferi.

The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected of measles (rubeola) infection. This assay is intended for use as an aid in the diagnosis of a current or recent measles (rubeola) infection in conjunction with other clinical information and laboratory findings. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at a point of care. This test is not intended for use in screening blood and plasma donors.

The Trinity Biotech Captia™ Measles IgM test is an Enzyme-Linked Immunosorbent Assays (ELISA). When measles antigen (Edmonston strain) is bound to the solid phase and brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgM globulin conjugated with horseradish peroxidase which will bind to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4. The contents of the wells turn yellow. The color, which is indicative of the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device. The Giardia Nitrocellulose Membrane Test Strip - above consist of - A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip. - B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip. - C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone. When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly. The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes. The test concept: Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region. Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone. A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane. Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.

Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a single use, rapid, lateral flow immunoassay to detect the presence of Cryptosporidium parvum antigen in unpreserved (fresh & frozen), preserved, and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The Premier Hb9210™ is an update of the predicate HPLC device, the Ultra2, which is the current model under K891235. The Premier Hb9210™ is a compact, integrated HPLC system and workstation with the Trinity Biotech AFFINITY Software for the quantitative determination of glycated hemoglobin using the patented boronate affinity chemistry with high performance liquid chromatography.

The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

The Destiny Max instrument performs coagulation testing (clotting, chromogenic and immuno-turbidimetric) using human samples. The system is comprised of an instrument (Destiny Max Analyzer) that performs the tasks necessary to general an assay result together with a Personal Computer (PC) that receives the user's secueeds and provides the results. The assays used with the Destiny Max are generally requences detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations.

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performanace in these populations and with automated equipment

The Captia™ HSV 1 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assav (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 1 antigen. The Captia™ HSV 1 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection. For In Vitro Diagnostic Use Only. The Captia™ HSV 1 IgG Type Specific test is an Enzyme-Linked Immunosorbent assay to detect IgG antibodies to Herpes simplex 1 antigen. Purified recombinant HSV gG1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) I Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performance in these populations and with automated equipment.

The CaptiaTM HSV 2 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 2 antigen. The Captia™ HSV 2 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection. Purified recombinant HSV gG2 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.