Search Results

The IOS Prostate Specific Antigen Test Cartridges are to be used for the quantitative determination of prostate specific antigen levels in serum as an aid in the management of patients diagnosed with prostate cancer. They are intended to be used with the IOS instrument in clinical laboratories, physicians' office laboratories, and other alternate sites of use close to the point of patient care. The IOS PSA Controls are to be used to assist in monitoring accuracy and precision in the IOS PSA Test Cartridges.

Prostate Specific Antigen Test Cartridges: Prostate specific antigen (PSA) is a serine protease first discovered in seminal plasma which has a molecular weight of approximately 30,000 Daltons. 14 PSA is secreted by normal prostatic epithelial cells as well as by diseased prostatic tissue. When PSA is released into the blood, it is inactivated by the major extracellular serine protease inhibitors, alpha-2-macroglobulin and alpha-1-antichymotrypsin. The portion of PSA that is inactivated by alpha-2-macroglobulin is undetectable by immunoassays measuring total PSA.46 The fraction of PSA bound to alpha-1-antichymotrypsin (~90 kDa) is detectable and is the predominate form of PSA in human serum, constituting 73 -95% of circulating PSA. The remaining 5 - 27% of detectable PSA exists in a "free" enzymatically inactive state (~30 kDa), and is found to be at higher proportions in patients with benign prostatic hyperplasia. The IOS PSA assay measures free and total PSA in an equimolar fashion. Longitudinal determinations of PSA have been shown to be useful when monitoring prostate cancer patients. Serial PSA measurements are indicative of recurrence of disease or metastatic progression if PSA levels continue to rise after surgical or medical treatment. Serial PSA measurements that decrease to undetectable levels indicate successful treatment of disease.8-11 PSA levels have also been shown to be elevated in patients with benign prostatic hyperplasia (BPH) and prostatitis. 10 PSA levels are not elevated in cancers of the breast, lung, colon, rectum, stomach, pancreas, or thyroid. PSA testing alone is not be used as a screening test for prostate cancer or in the staging of prostatic cancer. PSA testing is accepted as an adjunctive test in managing the treatment of patients with prostate cancer. 12,13 Principle of the Test The IOS PSA test is a two-site sandwich immunoassay. PSA in the patient serum binds to an enzyme-labeled monoclonal anti-PSA conjugate. This PSA:conjugate complex is captured by polyclonal anti-PSA antibody immobilized on the plastic surface, forming a capture-antigen-conjugate sandwich. After an incubation period, excess sample and conjugate are washed away and substrate is added. The substrate reacts with the conjugate: PSA complex captured on the surface and produces a fluorescent signal. The rate of the enzyme-substrate reaction is directly proportional to the amount of conjugate bound, which is directly proportional to the amount of PSA present in the patient sample. All reagents necessary to perform the test are dried on the IOS test cartridge, and are rehydrated by the addition of patient sample, or by the addition of IOS buffer by the instrument. To perform the test, the operator inserts an IOS PSA cartridge into the IOS instrument. When prompted, the operator adds sample to the sample well and starts the test sequence. The instrument draws the cartridge inside to mix the patient sample, which also rehydrates the anti-PSA conjugate. A short incubation period allows the serum and conjugate to react. The PSA:conjugate complex then flows into the incubation/reaction chamber where binding to the solid phase occurs. At the end of this incubation time, excess patient sample and conjugate are aspirated out of the incubation/reaction chamber and the incubation/reaction chamber is washed using buffer added by the instrument. Buffer is also used to rehydrate the substrate necessary for signal generation and quantitation of PSA in another reagent chamber; rehydrated substrate is then allowed to enter the incubation/reaction chamber. The fluorescent signal produced is read as a rate by front-surface fluorometry, compared to the rates produced by a series of calibrators stored in the instrument memory, and the amount of PSA present in the patient sample is calculated from the stored calibration curve. IOS PSA Controls: The use of materials derived from human blood to monitor quality control of clinical chemistry testing in the clinical laboratory has been widely established over the past several years. The Biocircuits IOS PSA Controls are two levels of bloodbased material for use with Biocircuits IOS PSA Test Cartridges. To run a control, the operator inserts the Control Cartridge (packaged with the controls) into the IOS instrument. The instrument reads the lot number and ranges of acceptable values for the control solutions from the Control Cartridge barcode, and then ejects the Control Cartridge. The operator then inserts a test cartridge and follows the instrument prompts to identify the control level, apply control solutions, and begin the test sequence. The IOS instrument performs the required buffer additions to rehydrate assay reagents and perform wash steps as necessary, reads the fluorescence signal generated, and calculates and prints the control result just as it would if the cartridge were used to test a patient sample.

The IOS Free Thyroxine Test Cartridges are intended to be used for the quantitative determination of free (not protein bound) thyroxine (thyroid hormone) in serum for the diagnosis and treatment of thyroid diseases. They are intended to be used with the Biocircuits IOS® instrument in clinical laboratories, physician office laboratories, and other alternate sites of use close to the point of patient care. The IOS Controls are to be used to assist in monitoring accuracy and precision in the IOS immunoassay test cartridges.

The IOS Free T4 assay is a sequential immunoassay in which free T4 in the patient serum sample first binds to a monoclonal anti-T4 antibody; this free T4:anti-T4 complex is then captured by polyclonal goat-anti-mouse immobilized on the plastic surface. Excess ('uncomplexed') anti-T4 antibody also binds to the surface. After an incubation period, any excess sample and unbound anti-T4 antibody are removed. In the second step, alkaline phosphatase-labeled T4 ('conjugate') is added, and the conjugate binds to T4 binding sites on the uncomplexed anti-T4 antibody. After another incubation period, excess conjugate is washed away and substrate is added. The substrate reacts with the conjugate bound to uncomplexed anti-T4 antibody and produces a fluorescent signal. The level of fluorescence is directly proportional to the amount of conjugate bound to the uncomplexed anti-T4 antibody and inversely proportional to the amount of free T4:T4 antibody complex, and thus inversely proportional to the amount of free T4 present in the serum sample. All the reagents necessary to perform the test are dried in the IOS Free T4 Test Cartridge, and are rehydrated by addition of patient sample by the operator or by the addition of buffer by the instrument. To perform a test , the operator inserts an IOS Free T4 Test Cartridge into the IOS instrument. When prompted, the operator adds sample to the sample well and starts the test sequence. The instrument draws the cartridge inside and adds buffer to dilute the serum. The diluted serum rehydrates the dried reagent (mouse anti-T4 antibody) in the sample well. A short incubation period allows the serum and reagents to react. This mixture then flows into the incubation/ reaction chamber, where binding to the solid phase occurs. At the end of the incubation time, excess mixture is aspirated out of the incubation/reaction chamber by the instrument. Buffer is used to rehydrate conjugate in a separate chamber; rehydrated conjugate is allowed to enter the reaction chamber to bind to uncomplexed T4 antibody. At the end of this incubation time, excess conjugate is washed away by buffer dispensed by the instrument. Buffer is also used to rehydrate the substrate necessary for signal generation and quantitation in a third chamber: rehydrated substrate is then allowed to enter the incubation/reaction chamber. The signal produced is read as a rate by front-surface fluorometry, compared to the signal produced by a series of calibrators stored in instrument memory, and the amount of free T4 present in the patient sample is calculated from the stored calibration curve. IOS Controls: The use of materials derived from human blood to monitor quality control of clinical chemistry testing in the clinical laboratory has been widely established over the past several years. The Biocircuits IOS Controls are two levels of blood-based material for use with Biocircuits IOS Test Cartridges. To run a control, the operator inserts the Control Cartridge (packaged with the controls) into the IOS instrument. The instrument reads the lot number and ranges of acceptable values for the control solutions from the Control Cartidge barcode, and then ejects the Control Cartidge. The operator then inserts a test cartridge and follows the instrument prompts to identify the control level, apply control solutions, and begin the test sequence. The IOS instrument performs the required buffer additions to rehydrate assay reagents and perform wash steps as necessary, reads the fluorescence signal generated, and calculates and prints the control result just as it would if the cartridge were used to test a patient sample.

The IOS™ Quantitative hCG Test Cartridges are to be used for the quantitative determination of human chorionic gonadotropin (hCG) in serum for the early detection of pregnancy. They are intended to be used with the IOS™ instrument in clinical laboratories, physicians' office laboratories, and other alternate sites of use close to the point of patient care. The IOS™ Immunoassay Controls Kit is to be used to assist in monitoring accuracy and precision in the IOS™ immunoassay test cartridges.

Quantitative hCG Test Cartridges: Human chorionic gonadotropin is a glycoprotein that is synthesized by the placenta during pregnancy and appears in both serum and urine relatively soon after implantation of the developing embryo. The presence of hCG, and its rapid rise following conception, is thus the basis of pregnancy testing. (1) Quantitation of hCG can aid in the determination of ectopic pregnancy and spontaneous abortion (2, 3). hCG is also secreted by a wide variety of tumors: gestational trophoblastic tumors, testicular and prostatic tumors, and some breast cancers. (4,5). Human chorionic gonadotropin is composed of two noncovalently linked polypeptides: the alpha and beta subunits. The individual subunits lack biological activity, but become active when combined to form the intact hormone. The alpha subunit of hCG is structurally homologous to the alpha subunits of LH (luteinizing hormone), FSH (follicle stimulating hormone), and TSH (thyroid stimulating hormone). The beta subunit of each of the hormones is structurally unique and confers the biologic and immunologic specificity to each hormone. The beta subunit of hCG contains a unique chain of 30 carboxy-terminal amino acids that confers its specificity (1). Monoclonal antibodies directed against this portion of the beta subunit permit differentiation between hCG and the other pituitary glycoprotein hormones. Principle of the Test: The IOS™ Quantitative hCG test is a two-site sandwich immunoassay which utilizes two antibodies directed against hCG: a polyclonal antibody immobilized on the plastic cartridge surface (capture antibody) and a monoclonal antibody labeled with alkaline phosphatase (detection antibody, conjugate). hCG in the patient sample binds to conjugate in the test cartridge, and this hCG-conjugate complex then binds to the immobilized capture antibody. After a short incubation period, unbound hCG-conjugate complex is washed away. Substrate is added, which reacts with the alkaline phosphatase conjugate-hCG-capture antibody 'sandwich' and produces a fluorescent signal. The level of fluorescence is directly proportional to the amount of bound hCG-conjugate, which is directly proportional to the amount of hCG present in the patient sample. All reagents necessary to perform the test are dried in the IOS™ cartridge, and are rehydrated by the addition of patient sample by the operator, or by the addition of buffer by the instrument. To perform a test, the operator inserts an IOS™ Quantitative hCG cartridge in the IOS™ instrument. When prompted, the operator adds sample well. A second portion of patient sample is diluted off-line, using the dilution vial supplied with the kit, and pipetted into the second well of the test cartridge. The operator starts the test sequence when sample addition is complete. Patient sample rehydrates conjugate dried in the sample well; the conjugate binds to hCG present in the patient serum sample. This hCG-conjugate complex then flows into the incubation/reaction chamber where it binds to the immobilized capture antibody. At the end of the incubation time, unbound sample-conjugate is washed away by buffer. Buffer is used to rehydrate the dried substrate necessary for signal generation and quantitation of hCG, and the rehydrated substrate is then delivered to the incubation/reaction chamber. The fluorescent signal produced is read as a rate by front-surface fluorometry, compared to the rates produced by a series of calibrators stored in the instrument memory, and the amount of hCG present in the patient sample is calculated from the stored calibration curve. If the signal from the first track (undiluted patient serum) is higher than that of the highest calibrator, the instrument will take a reading from the second track (user-diluted sample) to obtain a quantitative value for the patient sample. This increases the assay range 2500 mIU/mL (undiluted track) to 250,000 mIU/mL (diluted track). Immunoassay Controls: The use of materials derived from human blood to monitor quality control of clinical chemistry testing in the clinical laboratory has been widely established over the past several years. The Biocircuits IOS™ Immunoassay Controls are two levels of bloodbased material for use with Biocircuits IOS™ Test Cartridges. To run a control, the operator inserts the Control Cartridge (packaged with the controls) into the IOS™ instrument. The instrument reads the lot number and ranges of acceptable values for the control solutions from the Control Cartridge barcode, and then ejects the Control Cartridge. The operator then inserts a test cartridge and follows the instrument prompts to identify the control level, apply control solutions, and begin the test sequence. The IOS™ instrument performs the required buffer additions to rehydrate assay reagents and perform wash steps as necessary, reads the fluorescence signal generated, and calculates and prints the control result just as it would if the cartridge were used to test a patient sample.

TSH: The IOS™ TSH Test Cartridge is to be used for the quantitative determination of thyroid stimulating hormone (TSH, thyrotropin) levels in serum using the Biocircuits IOS™ system. Thyroid Controls: The IOS™ Thyroid Controls Kit is to be used to assist in monitoring accuracy and precision in the IOS™ thyroid assays.

Thyroid stimulating hormone (TSH) is a glycoprotein with a molecular weight of about 28,000 daltons that is secreted by the anterior pituitary gland. TSH interacts with a specific receptor on the thyroid gland cell surface, stimulating production and secretion of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). Secretion of TSH is regulated by two factors: 1) a hormone secreted by the hypothalamus called thyrotropin releasing hormone (TRH) which stimulates the pituitary to produce and release TSH; and 2) the concentration of unbound thyroid hormones T4 and T3 in the interstitial fluid of the brain. An increase of the concentrations of T4 and T3 inhibits the production and secretion of TSH, while a decrease in T4 and T3 levels stimulates production and secretion of TSH, forming a negative feedback mechanism. Failure at any level of regulation of the hypothalamic-pituitary-thyroid axis will result in either under-production (hypothyroidism) or over-production (hyperthyroidism) of T4 and/or T3. Primary hypothyroidism is associated with low thyroid hormone levels and elevated TSH levels, while secondary (pituitary) and tertiary (hypothalamic) forms of hypothyroidism are associated with both low levels of T4 and/or T3 and low-to-undetectable levels of TSH. All three forms of hypothyroidism can be differentiated by the patient's TSH response to TRH. Primary hyperthyroidism is associated with high levels of thyroid hormones and very low or undetectable levels of TSH. The TRH challenge test has been used to confirm primary hyperthyroidism. More recently, sensitive TSH assays have been developed which can differentiate overtly thyrotoxic patients from euthyroid individuals. TSH is composed of two noncovalently linked subunits, designated "alpha" and "beta". The alpha portion is essentially identical to the alpha subunits of human luteinizing hormone (hLH), human follicle stimulating hormone (hFSH), and human chorionic gonadotropin (hCG), differing only in carbohydrate moieties. The beta subunits of each of these hormones is structurally unique and contains the biologic and immunologic specificity. Both subunits are needed for biological activity. The Biocircuits IOS™ TSH assay uses a monoclonal antibody against the beta subunit of TSH to specifically capture the patient TSH, and a polyclonal antibody also against the beta subunit for the enzyme conjugate. This allows specific determination of the concentration of TSH without cross-reactivity with other glycoprotein hormones. Principle of the Test: TSH: The IOS™ TSH test is a two-site sandwich immunoassay. TSH in the patient sample binds to monoclonal anti-TSH antibody in the test cartridge. After a short incubation time, excess sample is washed away and enzyme-labeled polyclonal anti-TSH antibody (conjugate) is added, which binds to any antibody-bound TSH, forming an antibody-antigen-labeled antibody sandwich. After another short incubation time, excess conjugate is washed away and substrate is added. The rate of the enzyme-substrate reaction is directly proportional to the amount of conjugate bound, which is directly proportional to the amount of TSH present in the patient sample. All reagents necessary to perform the test are dried in the IOSTM cartridge, and are rehydrated by the addition of patient sample by the operator, or by the addition of buffer by the instrument. To perform a test, the operator inserts an IOS™ TSH cartridge into the IOS™ instrument. When prompted, the operator adds sample to the sample well and starts the test sequence. The instrument draws the cartridge inside to be incubated. Patient sample flows into the incubation/reaction chamber where patient TSH binds to anti-TSH antibody. At the end of the sample incubation time, excess patient sample is washed away using buffer added by the instrument. Buffer is also added by the instrument to rehydrate dried conjugate in a separate reagent chamber for the next step; the rehydrated conjugate is then allowed to enter the incubation/reaction chamber and bind to antibody-bound TSH. At the end of the conjugate incubation time, excess conjugate is washed away by buffer. Buffer is used to rehydrate the substrate necessary for signal generation and quantitation of TSH in a second reagent chamber; rehydrated substrate is then allowed to enter the incubation/reaction chamber. The fluorescent signal produced is read as a rate by front-surface fluorometry, compared to the rates produced by a series of calibrators stored in instrument memory, and the amount of TSH present in the patient sample is calculated from the stored calibration curve. Thyroid Controls: The use of materials derived from human blood to monitor quality control of clinical chemistry testing in the clinical laboratory has been widely established over the past several years. (1) The Biocircuits IOS™ Thyroid Controls are two levels of blood-based material for use with Biocircuits IOSTM thyroid assays test cartridges (T4/TU, T4, or TSH), To run a control, the operator inserts the Thyroid Control Cartridge (packaged with the controls) into the IOS™ instrument. The instrument reads the lot number and ranges of acceptable values for the control solutions from the Control Cartridge barcode, and then ejects the Control Cartridge. The operator then inserts a test cartridge and follows the instrument prompts to identify the control level, apply control solutions, and begin the test sequence. The IOS™ instrument performs the required buffer additions to rehydrate assay reagents and perform wash steps as necessary, reads the fluorescence signal generated, and calculates and prints the control result just as it would if the cartridge were used to test a patient sample.

The IOS™ Serum Pregnancy Test Cartridge is to be used for the qualitative determination of human chorionic gonadotropin (hCG) in serum for the early detection of pregnancy. It is intended to be used with the IOS™ instrument in clinical laboratories, physicians' office laboratories, and other alternate sites of use close to the point of patient care. The IOS™ Immunoassay Controls Kit is to be used to assist in monitoring accuracy and precision in the IOSTM immunoassay test cartridges.

Serum Pregnancy Test Cartridges: Human chorionic gonadotropin is a glycoprotein that is synthesized by the placenta during pregnancy. hCG appears in both serum and urine relatively soon after implantation of the developing embryo. The presence of hCG, and its rapid rise following conception, is thus the basis of pregnancy testing. hCG testing can aid in the determination of ectopic pregnancy and spontaneous abortion. hCG is also secreted by a wide variety of tumors: gestational trophoblastic tumors, testicular and prostatic tumors, and some breast cancers. hCG is composed of two noncovalently linked polypeptides: the alpha and beta subunits. The individual subunits lack biological activity, but become active when linked to form the intact hormone. The alpha subunit of hCG is structurally similar to the alpha subunits of LH (luteinizing hormone), FSH (follicle stimulating hormone), and TSH (thyroid stimulating hormone). The beta subunits of each of the hormones are structurally unique and confer the biologic and immunologic specificity to each hormone. The beta subunit of hCG contains a unique chain of 30 carboxy-terminal amino acids that confers its specificity (1). Monoclonal antibodies directed against this portion of the beta subunit permit differentiation between hCG and the other pituitary glycoprotein hormones. The IOS™ Serum Pregnancy test is a two-site simultaneous sandwich immunoassay which utilizes two antibodies directed against intact hCG: a polyclonal antibody immobilized on the plastic cartridge surface (capture antibody) and a monoclonal antibody labeled with alkaline phosphatase (detection antibody, 'conjugate'). hCG in the patient sample binds to conjugate in the test cartridge, and this hCG-conjugate complex then binds to the immobilized capture antibody. After a short incubation period, excess hCG-conjugate complex is washed away. Substrate is added, which reacts with the alkaline phosphatase conjugate-hCG-capture antibody 'sandwich' and produces a fluorescent signal. The level of fluorescence is directly proportional to the amount of bound hCG-conjugate, which is directly proportional to the amount of hCG present in the patient sample. All reagents necessary to perform the test are dried in the IOSTM cartridge, and are rehydrated by the addition of patient sample by the operator, or by the addition of buffer by the instrument. To perform a test, the operator inserts an IOS™ Serum Pregnancy Test Cartridge in the IOS™ instrument. When prompted, the operator adds sample well. Each cartidge can test two different patient samples, with one patient sample added to the left well and the second to the right well. The operator starts the test sequence when sample addition is complete. Patient sample rehydrates conjugate dried in the sample well; the conjugate binds to hCG present in the patient serum sample. This hCG-conjugate complex then flows into the incubation/reaction chamber where it binds to the immobilized capture antibody. At the end of the incubation time, excess sample-conjugate is washed away by buffer. Buffer is used to rehydrate the dried substrate necessary for signal generation and quantitation of hCC, in a second reaction chamber. Substrate flows into the incubation/reaction chamber where signal is produced as a result of substrate reacting with conjugate bound to captured patient hCG (the 'sandwich'). The fluorescent signal is read as a rate by front-surface fluorometry, compared to the rate for the cut-off value stored in the barcode on the test cartridge, and determined to be higher or lower than the cut-off value. Immunoassay Controls: The use of materials derived from human blood to monitor quality control of clinical chemistry testing in the clinical laboratory has been widely established over the past several years. The Biocircuits IOS™ Immunoassay Controls are two levels of bloodbased material for use with Biocircuits IOS™ Test Cartridges. To run a control, the operator inserts the Control Cartridge (packaged with the controls) into the IOS™ instrument. The instrument reads the lot number and ranges of acceptable values for the control solutions from the Control Cartridge barcode, and then ejects the Control Cartridge. The operator then inserts a test cartridge and follows the instrument prompts to identify the control level, apply control solutions, and begin the test sequence. The IOS™ instrument performs the required buffer additions to rehydrate assay reagents and perform wash steps as necessary, reads the fluorescence signal generated, and calculates and prints the control result just as it would if the cartridge were used to test a patient sample.