Assays
Molecular HSV test for vaginal lesion swabs
The MultiCode-RTx HSV 1&2 Kit is the first FDA-cleared molecular HSV test for vaginal-lesion swabs. The test provides PCR-based qualitative detection and typing for both HSV-1 and HSV-2 in approximately four hours utilizing a commonly available nucleic-acid extraction system and real-time PCR instrument. Previously, labs had to rely on culture, serology, or laboratory-developed PCR assays to provide results. The test is not FDA-cleared for use in cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.
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EraGen Biosciences
Identify women at highest risk for cervical cancer
The cobas HPV (human papillomavirus) test identifies women at highest risk for developing cervical cancer. The test is a qualitative in-vitro test for the detection of HPV in patient specimens. The test utilizes amplification of target DNA by PCR and nucleic-acid hybridization for the detection of 14 high-risk HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the other high-risk types. This test is designed to help physicians make early, more accurate decisions about patient care, which may prevent many women from developing cervical cancer.
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Roche
HbA1c in pre-filled cartridges
The Direct HbA1c test is available in pre-filled cartridges for use on Beckman Synchron CX, DX, and LX chemistry analyzers. This assay has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c. Each kit includes two 90-test HbA1c cartridges and 30-mL of lyse. Also available are whole blood HbA1c controls. This format ensures that dilution and lysing are done properly. Calibration is stable for 14 days. HbA1c is determined directly and does not depend on a calculation using a hemoglobin and an A1c result, avoiding the need to run two assays to get one result.
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Carolina Liquid Chemistries
Testing fertility and reproductive health
LOCI Fertility Assays are available on Dimension Vista Intelligent Lab Systems. LOCI technology requires fewer reaction steps (no need for washing or separation steps), resulting in fast turnaround times. LH (luteinizing hormone), FSH (follicle-stimulating hormone), and prolactin are the latest fertility assays available. LH and FSH are useful in the clinical evaluation of gonadal and pituitary disorders, while prolactin is used in the diagnosis and treatment of disorders of the anterior pituitary gland and hypothalamus portion of the brain.
Siemens Healthcare Diagnostics
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Siemens Healthcare Diagnostics
Assay measures DNA viral load of hepatitis B
Using the company’s m2000 automated instrument system for molecular-diagnostic testing, the RealTime HBV assay, based on real-time polymerase-chain-reaction, or PCR, technology, offers sensitive measurement of hepatitis B (HBV) in human plasma or serum from individuals chronically infected with HBV. To help physicians make and adjust treatment decisions for newly diagnosed patients and those taking antiviral medications, the assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient’s blood.
Abbott Molecular
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Detect HIV antigens and antibodies
The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women. The assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.
Abbott Diagnostics
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Streamlined GBS testing
The BD MAX GBS assay is an in vitro diagnostic test for the detection of Group B Streptococcus (GBS) DNA in Lim Broth cultures obtained from vaginal/rectal swab specimens from antepartum pregnant women. The BD MAX System — an automated workstation for molecular testing — automates cell lysis, nucleic-acid extraction, PCR set-up, amplification, and detection. The assay identifies GBS in just over an hour from Lim Broth, which can help ensure that colonization status is available in the case of pre-term delivery. The system offers walkaway convenience for up to 24 samples in approximately 2.5 hours.
BD Diagnostics
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Intact parathyroid hormone assay
The VITROS iPTH Assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intraoperative testing with results available in 18 minutes. The iPTH assay is designed to be run in a fully automated, random-access format on the VITROS ECi/ECiQ and 3600 Immunodiagnostic systems, and can also be run on the VITROS 5600 Integrated System to combine clinical chemistry, routine, and infectious-disease immunoassay testing on a single platform. Equivalent analytical results are generated across all three systems. Measuring intact parathyroid hormone levels aids in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Ortho Clinical Diagnostics
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Test for heroin on bench-top analyzer
Because the 6-Acetylmorphine assay (6-AM) is specific to heroin use, the test aids in eliminating cross-reactivity with codeine, morphine, and other drugs. Physicians can perform the test in their offices using the bench-top BioLis 24i chemistry analyzer, which offers more than 16 drugs-of-abuse tests and more than 80 different tests overall. 6-AM is a unique metabolite of heroin (3,6 diacetylmorphine) and cannot be synthesized in the body from other opioids such as codeine or morphine. The presence of 6-AM in the urine confirms that heroin was the opioid used by the patient. The BioLis 24i uses permanent reaction cuvettes, eliminating the need for expensive disposable cuvettes that require hazardous-waste disposal.
Carolina Liquid Chemistries
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Folate assay for diagnosis of anemia
The AIA-Pack RBC Folate assay is designed for the quantitative measurement of red blood cell folate (RBC folate) in whole-blood (heparin or EDTA) samples on Tosoh AIA system analyzers. For in vitro diagnostic use only, the AIA-Pack RBC Folate assay is available on the AIA-600II, AIA-1800, and AIA-2000 system analyzers. The assay range is from 0.62 ng/mL to 24 ng/mL. Reagents come in single, unitized cups that require no pre-mixing, no pre-measuring, no on-board refrigeration, and produce no excess waste.The cups are bar coded for test identification and inventory management.
Tosoh Bioscience
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Rapid thyroid stimulating hormone screen
Designed to be an initial screening device to aid in the diagnosis of hypothyroidism, the CLIA-waived ThyroTest is a rapid thyroid-stimulating hormone (TSH) test used for symptomatic patients. This test screens patients with symptoms of hypothyroidism by measuring the level of TSH, yielding a positive result if the level of TSH is higher than 5 µIU/mL; the standard for the upper limits of normal for TSH. Using two drops of blood from a fi ngerstick and fi ve drops of diluent, a qualitative TSH level is indicated in 10 minutes. Positive results indicate a patient’s abnormally high level but does not give an quantitative value. The TSH test also includes controls.
ThyroTec
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Automated HIV antibody test
The OCD VITROS Anti-HIV 1+2 Assay for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems, is an in vitro diagnostic immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma, providing results in less than 50 minutes. The systems’ random-access and automated features allow tests to be run at any time and in any order as needed, eliminating the need for expensive batch testing of multiple patient samples. Each kit includes 100 tests and has a shelf life of the 44 weeks. The VITROS 5600 System offers a complete infectious disease testing menu, including Anti-HIV 1+2 and rubella.
Ortho Clinical Diagnostics
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Assess response to antiplatelet medication
The VerifyNow P2Y12 Assay is a whole-blood assay used in the lab or point-of-care setting to measure the level of platelet P2Y12 receptor blockade. The test uses ADP as an agonist to induce platelet activation and ascertain the level of platelet reactivity due to thienopyridines. Utilizing an automated analyzer with single-use, disposable assays, the system can also help assess patient response to other antiplatelet medications such as aspirin, clopidogrel, prasugel, and GP IIb/IIIa inhibitors. The system provides results in less than five minutes for most assays. The system is also equipped with internal assay controls, electronic quality control testing, and two levels of wet quality controls to ensure the instrument and assays are performing as expected.
Accumetrics
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Hepcidin hormone testing kit
The Hepcidin 25 (C-Terminal) ELISA Kit measures the hormone hepcidin to quickly diagnose iron disorders, including hemochromatosis and anemia. In recent years, scientists discovered that hepcidin helps regulate the amount of iron in humans. Unbalanced iron levels can lead to many common medical conditions including anemia and iron-overload diseases. Unbalanced iron levels also can occur in chronic kidney disease, inflammation, or diabetes mellitus. The measurement results will offer information to clinicians to help diagnose and treat conditions including iron-deficiency diseases.
DRG International
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Molecular diagnostic MRSA test
NucliSENS EasyQ MRSA, an automated test for methicillin-resistant Staphylococcus aureus (MRSA) for the NucliSENS system, detects seven MRSA types, covering the most prevalent S aureus strains (MREJ types 1, 2, 3, 4, 5, 7, and 12). The simultaneous detection of two targets, reducing the risk of a false-positive result, improves its specificity and avoids re-testing, inappropriate antibiotic treatment, and isolation of patients. The test provides rapid results, with a turnaround time of less than three hours, and the flexibility of being used for batch (46 tests) or stand-alone (one test) screening.
bioMérieux
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Fetal maternal hemorrhage screening test
FETALSCREEN II Fetal Maternal Hemorrhage Screening Test is a simple, qualitative test that detects D (Rho) positive fetal red-blood cells in the maternal circulation of pregnant Rh-negative women for the detection, prevention, and management of hemolytic disease of the newborn (HDN), a serious autoimmune disease caused by incompatibility between the mother’s and baby’s blood. The test uses an innovative blend of monoclonal antibodies for stability and accuracy; enzyme-treated indicator cells to facilitate robust reactivity and results clarity; and fewer microscopic fields to simplify results reading and interpretation.
Ortho Clinical Diagnostics
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Reproductive disease test
The Access Sex Hormone Binding Globulin (SHBG) assay is for use in the differential diagnosis of conditions of chronic or excessive androgenic activity. The assay may also be used in conjunction with the Access testosterone assay to provide a calculated free androgen index. SHBG is responsible for the transport of testosterone and estradiol in the blood. Less than 2% of sex hormones are free, with the remainder bound with high affinity to SHBG and low affinity to albumin. The binding of sex hormones to SHBG inhibits their function; therefore, bioavailability of sex hormones is influenced by the level of SHBG.
Beckman Coulter
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Diagnostic kit measures hormone Hepcidin
The
enzyme-linked immunosorbant assay DRG Hepcidin 25 (C-Terminal) ELISA
Kit offers a fast and accurate method to test patient Hepcidin
levels. The measurement results can offer more information to clinicians
to help diagnose and treat medical conditions including iron-deficiency
diseases. Hepcidin helps regulate the amount of iron in humans.
Unbalanced iron levels can lead to common medical conditions including
anemia, chronic kidney disease, and iron-overload diseases.
DRG International
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Detection of thyroid-stimulating immunoglobulins
The Thyretain TSI Reporter BioAssay is an in vitro diagnostic-use test that specifically detects
thyroid-stimulating immunoglobulins (TSI) in patient serum. The test is
used as an aid in the differential diagnosis of Graves’ disease.
Thyretain provides laboratories with the ability to test for TSI using
standard laboratory equipment, does not require the use of
radioactivity; and eliminates any ambiguity of test results that can be
confounded by the presence of non-TSI auto-antibodies. The kit includes
a genetically engineered cell line that produces the reporter enzyme
luciferase in response to specific TSI binding, and the amount of
luciferase produced is then rapidly detected using a luminometer.
Diagnostic HYBRIDS
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Early detection of renal failure
Gentian
Cystatin C Immunoassay (CYSX) is an assay for the quantitative
determination of cystatin C in human serum and plasma. When used on the
company’s Synchron and UniCel Clinical Systems, Gentian CYSX can be used
in the diagnosis and treatment of renal disease. Reagents and
calibrators for the assay are liquid and ready to use, eliminating the
need for mixing, hydrating, or pre-diluting before testing. A number of
studies report that cystatin C assays are sensitive. Cystatin C is an
early indicator of decreased renal function and may be a superior marker
over creatinine in the estimation of glomerular filtration rate, or GFR,
the overall index of kidney function.
Beckman Coulter
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