QuidelOrtho

PlGF Test
Quidel Triage PlGF Test

The Quidel Triage PlGF Test is intended for the diagnosis of preterm pre-eclampsia and as an aid in the prognosis of delivery, in women presenting with signs and symptoms of pre-eclampsia after 20 weeks and before 35 weeks of gestation. It quickly, economically, and effectively identifies placental dysfunction as a root cause of preterm pre-eclampsia and is used in conjunction with other clinical information.

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Troponin I Test
Quidel TriageTrue High Sensitivity Troponin I Test

The Quidel TriageTrue High Sensitivity Troponin I Test is a fluorescence immunoassay that provides quantitative determination of Troponin I in EDTA anticoagulated whole blood and plasma specimens. It runs on the Quidel Triage MeterPro and can be used as an aid in the diagnosis of myocardial infarction.

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POC Cardiac Panel
Quidel Triage

The Quidel Triage cardiac panel is a rapid, point-of-care fluorescence immunoassay designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. It is used with the Quidel Triage MeterPro and can be used as an aid in the diagnosis of myocardial infarction (injury).

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Strep A Test
QuickVue Dipstick Strep A Test

The QuickVue Dipstick Strep A Test is a rapid diagnostic tool for detecting group A streptococcal antigen in throat swab specimens. This test provides results in just 5 minutes, offering high sensitivity and specificity for identifying streptococcal infections. The included internal and external controls ensure the reliability of results, while the simple procedure and clear illustrations make it easy for laboratory personnel to perform the test accurately. It is an essential tool for diagnosing strep throat in clinical settings.

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Myocardial Infarction Test
Quidel Triage Cardio3 Panel

The Quidel Triage Cardio3 Panel is a fluorescence immunoassay used with the Quidel Triage MeterPro to measure CK-MB, Troponin I, and BNP levels in plasma or whole blood. The panel aids in diagnosing and assessing the severity of acute coronary syndromes and congestive heart failure. With a quick turnaround time of about 20 minutes, it offers valuable risk assessment and differential diagnosis capabilities, enhancing clinical decision-making for patients with heart-related conditions.

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Troponin I Test
Quidel Triage Troponin I Test

The Quidel Triage Troponin I Test is a next-generation fluorescence immunoassay used with the Triage MeterPro for quantitative detection of cardiac troponin I. It provides sensitive and specific results to aid in the diagnosis of myocardial infarction. With fast turnaround time and point-of-care convenience, this assay enhances emergency cardiac care by allowing early detection and risk assessment of acute coronary syndromes. Its compact format makes it ideal for urgent and outpatient settings.

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Troponin I & BNP Test
Quidel Triage Cardio2 Panel

The Quidel Triage Cardio2 Panel is a fluorescence immunoassay designed for use with the portable Triage MeterPro system. It provides quantitative measurements of next-generation troponin I and B-type natriuretic peptide (BNP), critical biomarkers for diagnosing acute coronary syndromes and heart failure. This point-of-care test enables rapid risk stratification and timely clinical decision-making, especially in emergency settings. It offers high sensitivity, accurate quantification, and supports efficient patient triage and cardiac event evaluation.

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D-Dimer Test
Quidel Triage D-Dimer Test

The Quidel Triage D-Dimer Test is a rapid, quantitative fluorescence immunoassay used to assess patients with suspected thromboembolic conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). Designed for use with the Quidel Triage MeterPro, the test provides fast and accurate results at the point of care. It supports early decision-making and aids in ruling out serious clotting conditions in emergency and acute care settings.

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TSI Assay
Thyretain Turbo TSI BioAssay

Thyretain Turbo TSI BioAssay detects thyroid stimulating autoantibodies (TSI) in human serum. This one-hour room temperature assay delivers rapid and reproducible results without requiring cell culture. Ideal for moderate to high-volume labs, it processes up to 87 samples per plate. The assay aids in differentiating Graves' disease in conjunction with clinical evaluation. Its specificity, sensitivity, and ease-of-use make it a valuable tool in thyroid disorder diagnostics and patient monitoring.

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hCG Urine Test
QuickVue hCG Urine Test

The QuickVue hCG Urine Test is a rapid immunoassay for detecting human chorionic gonadotropin (hCG) in urine. With results available in just 3 minutes and a sensitivity of 25 mIU/mL, it offers accurate and early pregnancy detection.

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Lactoferrin Test
QuickVue TLI Lactoferrin Test

The QuickVue TLI Lactoferrin Test detects elevated lactoferrin levels in human fecal specimens, serving as a marker for intestinal inflammation. Delivering results within 10 minutes, it aids in distinguishing active inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS).

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H. pylori Test
QuickVue TLI H. pylori Stool Antigen Test

The QuickVue TLI H. pylori Stool Antigen Test is a rapid immunoassay that detects H. pylori antigen in fecal specimens, supporting diagnosis and treatment monitoring of infections. With results in under 30 minutes and no instrumentation required, it provides operational efficiency and reliable outcomes in clinical practice.

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hCG Test
QuickVue+ hCG Combo Test

The QuickVue+ hCG Combo Test is a rapid immunoassay for detecting hCG in serum or urine, aiding early pregnancy diagnosis. It delivers results within 3–5 minutes, offering high sensitivity and ease of use for clinical and point-of-care settings.

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Respiratory Syncytial Virus Test
QuickVue RSV Test

The QuickVue RSV Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger).  One reagent means fewer steps, easy to perform testing, and minimal training, allowing clinicians to test and treat in the same office visit with results in only 15 minutes.

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Campylobacter-Specific Antigen Test
QuickVue TLI Campylobacter Test

The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. It is designed to detect C. jejuni and C. coli in less than 30 minutes from patients with signs and symptoms of gastroenteritis.

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Group A Streptococcal Antigen Test
QuickVue+ Strep A Test

The QuickVue+ Strep A test detects group A streptococcal antigen directly from throat swabs and beta-hemolytic colonies on blood agar plates. Two reagents mean fewer steps, easy to perform testing and minimal training, allowing clinicians to test and treat in the same office visit with results in only 5 minutes.

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Human Chorionic Gonadotropin Test
QuickVue hCG Combo Test

The QuickVue hCG combo test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. Its high sensitivity allows it to detect low hCG levels as early as 2-3 days before expected menses while the two-color result makes it easy to read and interpret.

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Group A Streptococcal Antigen Test
QuickVue In-Line Strep A Test

The QuickVue In-Line Strep A test uses a unique in-line extraction to detect group A streptococcal antigen directly from patient throat swab specimens. This is a true one–step test and is the first rapid strep A test waived under CLIA '88 with its two–color results giving clear readability and proven accuracy for dependable results.

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Group A β-Hemolytic Streptococcus Assay
Solana Strep

The Solana Strep complete assay is a rapid in vitro diagnostic test for the qualitative detection of group A β-hemolytic Streptococcus (Streptococcus pyogenes), and pyogenic group C/G (streptococcus dysgalactiae) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana Strep complete assay, when performed on the Solana instrument, allows for the rapid, accurate detection of group A and pyogenic group C/G Strep without the need for culture confirmation.

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Respiratory Assays
Solana Respiratory Viral Panel (RVP)

The Solana Respiratory Viral Panel (RVP) combines two Solana respiratory assays, Solana Influenza A+B and Solana RSV + hMPV, to create a focused respiratory viral panel to detect and differentiate all four respiratory viruses (influenza A, influenza B, respiratory syncytial virus and human metapneumovirus) from a single patient sample. Solana Influenza A+B and Solana RSV + hMPV each amplify and detect viral RNA present in transport media containing nasopharyngeal or nasal swab specimens obtained from symptomatic patients, and can be used to test up to six patients at a time in just 45 minutes using Solana’s high-volume throughput.

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Trichomonas Assay
Solana Trichomonas

The Solana Trichomonas assay is a rapid in vitro diagnostic test for the qualitative detection of nucleic acids isolated from clinician-collected vaginal swab specimens or urine specimens obtained from asymptomatic or symptomatic patients to aid in the diagnosis of Trichomoniasis. The assay utilizes helicase-dependent amplification (HDA) and fluorescent probe-based detection in the Solana instrument to determine assay results, allowing for the rapid, accurate detection of Trichomonas.

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RSV & hMPV Test
Solana RSV + hMPV Assay

The Solana RSV + hMPV assay is a rapid qualitative in vitro diagnostic test for the detection and differentiation of respiratory syncytial virus (RSV) and Human metapneumovirus (hMPV) viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay which is performed in the Solana instrument amplifies and detects viral RNA present in transport media containing nasopharyngeal or nasal swab specimens obtained from symptomatic patients.

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Bordetella IVD Test
Solana Bordetella Complete Assay

The Solana Bordetella Complete assay is an in vitro diagnostic test for the qualitative detection of  Bordetella pertussis and Bordetella parapertussis  nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to  these bacterium species. The assay, when performed on the Solana instrument, allows for their rapid, accurate detection with results displayed on the touchscreen that can be saved to the instrument, printed, and sent to the LIS.

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HSV Real-Time PCR Test
Savanna HSV 1+2/VZV Assay

The Savanna HSV 1+2/VZV Assay is an automated, rapid multianalyte real-time PCR test intended for the simultaneous qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus with the Savanna Platform. By amplifying the presence of DNA isolated and purified from cutaneous or mucocutaneous lesion swab samples from symptomatic patients, the Savanna HSV 1+2/VZV Assay can aid in the diagnosis of patients with signs or symptoms of these viruses.

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Strep Molecular Assay
Lyra Direct Strep Assay

The Lyra Direct Strep Assay is a Real-Time PCR in vitro  diagnostic test for the rapid and qualitative detection and differentiation of Group A β-hemolytic Streptococcus and pyogenic Group C and G β-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from symptomatic patients. It provides test results in less than 70 minutes for the identification of Group A and Group C or G using a one-step reagent set-up and three-step sample prep, and is available for use on the Applied Biosystems 7500 series of instruments.

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H. pylori Test
QuickVue H. pylori Test

The QuickVue H. pylori Test detects IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood in an easy-to-perform one-step procedure. It utilizes a convenient, non-invasive, and easy-to-perform test methodology to aid in the diagnosis of H. pylori.

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S. pneumoniae Test
Sofia S. pneumoniae Fluorescent Immunoassay (FIA)

The Sofia S. pneumoniae Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect Streptococcus pneumonia cell wall polysaccharide (CWPS) antigen in human urine of patients with pneumonia and in cerebral spinal fluid (CSF) specimens of patients with meningitis. The Sofia analyzer scans the test strip and measures the immunofluorescent signal by processing the results using method-specific algorithms and displays the test results on its display screen.

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RSV Dipstick Immunoassay
QuickVue RSV 10 Test

The QuickVue RSV 10 Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab or nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (five years of age and younger). The test has a time to result of 10 minutes or less and comes with positive as well as negative internal and external controls.

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Adenovirus (HAdV) Test
Lyra Adenovirus Assay

The Lyra Adenovirus Assay is a real-time PCR in vitro diagnostic assay for the qualitative detection of human Adenovirus (HAdV) viral DNA which has been isolated from nasal and nasopharyngeal swabs obtained from individuals exhibiting signs and symptoms of acute respiratory infections. The test detects, but does not differentiate, HAdV species (A, B, C, D, E, and F) or serotypes.

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Culture Fluorescent Test
D3 DFA Metapneumovirus Identification Kit

The D3 DFA Metapneumovirus Identification Kit is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection.

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Culture Fluorescent Test
D3 DFA Chlamydiae Culture Confirmation Kit

The D3 DFA Chlamydiae Culture Confirmation Kit is intended for the qualitative identification of Chlamydiae lipopolysaccharide (LPS) in inoculated cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). It uses a blend of two specific murine MAbs that are directly labeled with fluorescein isothiocyanate (FITC) for the qualitative detection of Chlamydiae in inoculated cell cultures.

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Culture Fluorescent Test
Thyretain TBI Blocking Reporter BioAssay

Thyretain TBI Blocking Reporter BioAssay is intended for the qualitative detection of blocking autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) in patients suspected of having autoimmune thyroid disease (AITD). The competitive cell-based assay (or bioassay) utilizes a genetically engineered cell line, expressing a chimeric TSHR and firefly luciferase reporter gene, capable of detecting serum TBI.

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Chlamydia Test
QuickVue Chlamydia Test

The QuickVue Chlamydia Test detects chlamydia directly from endocervical swab and cytology brush specimens and is used as an aid in the presumptive diagnosis of chlamydial infection. Using only two reagents and three drops of extracted sample, the rapid Chlamydia test offers high sensitivity and specificity in all patient populations, and is easy to perform and interpret.

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Group B Streptococcus Test
Solana GBS Assay

The Solana GBS Assay is an in vitro diagnostic test for the direct, qualitative detection of Group B Streptococcus from vaginal/rectal swabs following 18 to 24 hours incubation in LIM or Carrot broth cultures. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Thiolase (atoB) gene sequence and is intended for use only with the Solana instrument.

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Influenza A/B Test
Lyra Influenza A+B Assay

The Lyra Influenza A+B Assay is a multiplex real-time RT-PCR assay for the qualitative detection and identification of viral nucleic acids extracted from nasal swabs and nasopharyngeal swabs specimens. The real-time influenza test has been shown to detect HIN1, H3N2 and H7N9 subtypes but does not differentiate the subtypes from Influenza A.

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RSV & hMPV Test
Lyra RSV + hMPV Assay

The Lyra RSV + hMPV Assay is a multiplex real-time PCR assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) viral RNA extracted from nasal swabs and nasopharyngeal swab specimens. The real time RSV + hMPV test detects RSV and hMPV and is able to differentiate between them.

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TSI Stimulating Assay
Thyretain TSI Stimulating Reporter BioAssay

The Thyretain TSI Stimulating Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves’ disease.

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Influenza A/Respiratory Virus Test
D3 Duet DFA Influenza A/Respiratory Virus Screening Kit

The D3 Duet DFA Influenza A/Respiratory Virus Screening Kit, is intended for the qualitative detection and identification of influenza A, while screening for influenza B virus, respiratory syncytial virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection.

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Parainfluenza Virus Real-Time PCR Assay
Lyra Parainfluenza Virus Assay

The Lyra Parainfluenza Virus Assay is a multiplex real-time PCR assay for the qualitative detection and identification of viral nucleic acids extracted from nasal swabs and nasopharyngeal swabs from symptomatic patients. The assay has been shown to detect and differentiate parainfluenza virus types 1, 2 and 3, and has a convenient, one-step reagent set up performed at room temperature on the bench top, without the need for ice or other cooling accessories.

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Influenza A+B Test
Solana Influenza A+B Assay

The Solana Influenza A+B Assay is a rapid qualitative in vitro diagnostic test for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay amplifies and detects viral RNA present in transport media containing nasopharyngeal or nasal swab specimens obtained from symptomatic patients.

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POC BNP Fluorescence Immunoassay
Quidel Triage BNP Test

The Quidel Triage BNP Test is a rapid, point-of-care fluorescence immunoassay used with the Quidel Triage MeterPro. The test is used to measure B-type natriuretic peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The Quidel Triage BNP Test is the first rapid BNP immunoassay indicated for risk stratification for both acute coronary syndrome and heart failure.

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Bone Health Test
MicroVue PYD

MicroVue PYD provides a quantitative measure of pyridinium cross-links (Pyd and Dpd) as an indicator of type I collagen resorption, especially bone collagen. Pyd and Dpd are excreted unmetabolized in urine. It is intended for use as an indicator of type I collagen resorption, especially bone collagen.

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Mononucleosis Test
QuickVue+ Mononucleosis Test

The QuickVue+ Mononucleosis Test detects IgM heterophile antibodies in acute phase infections using serum, plasma or whole blood. It utilizes an extract of bovine erythrocytes which give a greater sensitivity and specificity than similar extracts prepared from sheep and horse erythrocytes. Clearly distinguishable +/– result, flexible specimen collection options, and a test complete indicator make rapid mono testing easy.

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C. difficile Assay
Solana C. difficile Assay

The Solana C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridioides (Clostridium) difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridioides (Clostridium) difficile-infection (CDI). It is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly-conserved fragment of the Toxin A gene sequence.

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C. difficile Assay
Lyra Direct C. difficile Assay

The Lyra Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the detection of toxin A gene (tcdA) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile-Associated Disease (CDAD). The assay has one-step reagent set-up and a three-step sample prep, with test results available in less than 70 minutes.

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RSV/Respiratory Virus Screening Kit
D3 Duet DFA RSV/Respiratory Virus Screening Kit

D3 Duet DFA RSV/Respiratory Virus Screening Kit is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection.

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Benchtop Real-Time PCR Analyzer
Savanna

Savanna is a compact benchtop instrument that utilizes real-time PCR to deliver customizable, multiplexed, automated molecular results in minutes. Savanna's unique Test Select feature allows users to customize testing panels, enabling targeted selection of the analytes that are most clinically relevant to patient care. Savanna’s workflow is simple and easy with no upfront sample or reagent preparation that allows testing to be decentralized.

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C. Difficile IVD Test
Solana C. difficile Assay

The Solana C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridioides (Clostridium) difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridioides (Clostridium) difficile-infection (CDI). The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly-conserved fragment of the Toxin A gene sequence.

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Respiratory Virus Screening and Identification Kit
D3 Ultra 8 DFA

The D3 Ultra 8 DFA (direct fluorescent antibody) Respiratory Virus Screening and Identification Kit is intended for the qualitative detection and identification of eight major respiratory viruses (influenza A, influenza B, respiratory syncytial virus (RSV), adenovirus, parainfluenza 1, parainfluenza 2 and parainfluenza 3 viruses, and metapneumovirus) in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).

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Auto Multiparameter POC Analyzer
Triage MeterPro

Triage MeterPro is designed to provide diagnostic results quickly and easily. With a variety of immunoassays and the ability to use whole blood, plasma, or urine, the platform gives labs a flexible solution at the point-of-care.

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Cardiac Panel
Triage Cardiac Panel

The Triage Cardiac Panel is a rapid, point of care fluorescence immunoassay used with the Triage MeterPro. This test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. This can be used as an aid in the diagnosis of myocardial infarction (injury).

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NT-proBNP Test
Triage NT-proBNP Test

The Triage NT-proBNP Test is a rapid, quantitative test for the measurement of NT-proBNP that helps empower heart failure treatment decisions or risk stratify patients with ACS at the point of care or in the laboratory.

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Respiratory Viral Panel
Savanna RVP4 Assay

The Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed real-time PCR test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection. Consisting of a self-contained, single-use assay cartridge, the Savanna RVP4 Assay requires no sample or reagent preparation prior to inserting the cartridge into the Savanna instrument. All sample and reagent preparation, nucleic acid extraction and amplification, and real-time detection of viral RNA is fully automated and completed by the Savanna instrument in approximately 22 minutes.

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HSV 1+2/VZV Assay
Lyra Direct HSV 1+2/VZV Assay

The Lyra Direct HSV 1+2/VZV Assay is a multiplex in vitro test that detects and differentiates Herpes simplex virus type 1, Herpes simplex virus type 2, and Varicella-zoster virus nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens obtained from symptomatic patients. The assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. The Lyra Direct HSV 1+2/VZV Assay is available for use on Applied Biosystems 7500 Fast Dx, QuantStudio Dx Real-Time PCR Instrument, and Cepheid SmartCycler II.

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HSV 1+2/VZV Assay
Solana HSV 1+2/VZV Assay

The Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens obtained from symptomatic patients. The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequence specific to HSV-1, HSV-2 and/or VZV using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.

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COVID-19 Rapid Test Cassette
RightSignCOVID-19 Rapid Test Cassette

The RightSignCOVID-19 Rapid Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium heparin, potassium EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate), and fingerstick whole blood. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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COVID-19 IgG/IgM Rapid Test
Ecotest COVID-19 IgG/IgM Rapid Test Devices

The Ecotest COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Ecotest COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

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COVID-19 Rapid Antibody Test
CoronaCHEK Rapid Antibody Convenience Kit

The CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma. The FDA EUA authorized and CLIA waived kit comes with one procedure card, one package insert, two fact sheets, and 20 individually packaged devices. Each package includes one test cassette, one dropper, one lancet, one single-use buffer, and one alcohol wipe.

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Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test
VITROS Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test

The VITROS Anti-SARS-CoV-2 Total Nucleocapsid Antibody Test is a highly accurate4 test for the qualitative detection of SARS-CoV-2 nucleocapsid antibodies in patients who have been infected with the SARS-CoV-2 virus. The test helps health care teams differentiate the cause of antibodies against SARS-CoV-2 and is processed on Ortho's VITROS Systems.

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Anti-SARS-CoV-2 IgG QN Antibody Assay
VITROS Anti-SARS-CoV-2 IgG QN Antibody Assay

The VITROS Anti-SARS-CoV-2 IgG QN Antibody assay is intended for the qualitative detection and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma and is processed on Ortho's trusted VITROS system. With 100% specificity and excellent sensitivity, the assay provides numerical values traceable to the World Health Organization (WHO) International Standard, which helps standardize SARS-CoV-2 serological methods and allows for unified data comparison across laboratories.

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SARS-CoV-2 Antigen Test
VITROS SARS-CoV-2 Antigen Test

The VITROS SARS-CoV-2 Antigen Test is a laboratory immunoassay for the in-vitro qualitative detection of the SARS-CoV-2 nucleocapsid antigen that delivers fast, high-volume testing for active infection with excellent specificity and sensitivity, making it a viable alternative to PCR testing. Results are reported as either reactive (positive) or non-reactive (negative) with no gray zone, providing healthcare systems and communities more capacity to quickly and accurately diagnose individuals with an active infection. The VITROS SARS-CoV-2 Antigen Test is fully compatible with Ortho’s VITROS XT 7600 and 5600 Integrated Systems and VITROS 3600 Immunodiagnostic System.

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SARS-CoV-2 Assay
Solana SARS-CoV-2 Assay

The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider. The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument. Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports.

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SARS-CoV-2 Antigen Test
QuickVue SARS Antigen Test

The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The test provides accurate and reliable results in 10 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

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Flu + SARS Antigen Test
Sofia 2 Flu + SARS Antigen FIA

The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the Point of Care.

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SARS-CoV-2 (COVID-19) Antibody Test
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test

The VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test is a COVID-19 IgG antibody test that detects the IgG antibody and offers 100% specificity. It offers greater choice in tracking and surveillance, patient management, and screening convalescent plasma. The test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and runs on Ortho's high-throughput, fully automated analyzers including its flagship VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System.

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SARS-CoV-2 (COVID-19) Antibody Test
40) VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack

The VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgG and IgM) to SARS-CoV-2 that can be used to detect immune response to the virus. The test can be used in epidemiological research to help better understand the spread of the disease and can also be used to aid in the diagnosis of suspected COVID-19 patients in conjunction with molecular tests. The test will run on Ortho’s flagship analyzer, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour. The test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and has also received CE Mark.

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SARS-CoV-2 Assay
Lyra Direct SARS-CoV-2 Assay

The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus and has a one-step reagent set-up and three-step sample prep with test results available in less than 70 minutes.

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SARS Antigen Fluorescent Immunoassay
Sofia SARS Antigen Fluorescent Immunoassay (FIA)

The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

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SARS-CoV-2 Assay
Lyra SARS-CoV-2 Assay

The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS easyMAG system or EMAG system, followed by RT-PCR on six thermocyclers.

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Chemistry System
VITROS XT 3400

The VITROS XT 3400 Chemistry System simultaneously performs two tests frequently ordered together on one VITROS XT MicroSlide and offers up to 40% higher throughput than current slides. Its double assay processing offers a 25% faster turnaround time on a common panel of assays with an average processing time of 7.5 minutes and allows for the lowest sample volume at 2.7μl.

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Integrated Chemistry System
VITROS XT Solutions

VITROS XT Solutions, which include the new VITROS XT 3400 Chemistry System and the VITROS XT 7600 Integrated System with new XT MicroSlides, help ensure the right result the first time, with an industry-leading 96.5% first-pass yield. They reduce the need for manual interventions such as those caused by reviews, reruns or redraws by 75% as compared to competitive systems and provides up to 300 more tests per day without delay for labs doing one million tests annually.

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HIV Assay
VITROS HIV Combo

The VITROS HIV Combo is a fourth generation assay for early detection as it tests for a combination of antibodies: HIV-1, HIV-2, as well as the HIV p24 antigen. With class-leading p24 antigen sensitivity that doesn't sacrifice specificity, it gives the utmost confidence in results.

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Lab Middleware
ORTHO CONNECT

The ORTHO CONNECT is a middleware solution that acts as a link between ORTHO instruments and the lab information system (LIS), bringing everything to the user’s fingertips to help streamline operations and maximize resources. Acting as an intermediary, it allows the systems to exchange data, perform data management and complete regulatory process tasks that neither can easily perform alone.

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Automated Pipetting & Processing System
ORTHO VIP

The ORTHO VERSEIA Integrated Processor (VIP) is an automated pipetting and processing system that brings together the ORTHO VERSEIA Pipetter and ORTHO Summit Processor to enable end-to-end pipetting and processing. It enables automated scheduling and upfront loading capacity of 544 samples, reagents, and consumables—for six hours of operator walk-away time, and also offers 22 hours of continuous processing ability.

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iFOB Test
QuickVue iFOB

The QuickVue iFOB (immunochemical Fecal Occult Blood) Test detects the presence of blood in stool specimens and provides results in five minutes. It requires only one specimen, and because it is specific to human hemoglobin, patients are not required to adhere to strict dietary or medication restrictions.

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Immunoassay Test
Sofia Strep A+ FIA

The Sofia Strep A+ FIA uses advanced immunofluorescence-based lateral-flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. It offers fast time to results of five minutes for truly rapid strep testing and uses self-contained test cassette that is clean, easy to use and dispose.

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Immunoassay Test
Solana GAS Assay

The Solana GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana GAS Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Group A Strep without the need for culture confirmation.

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Immunoassays
VITROS Assays Menu

The VITROS 5600 System broad menu of quality assays covers 90% of the menu needs and 99% of the testing volume for typical labs, providing actionable diagnostic insights that provide medical value for health care professionals. The 120 state-of-the-art assays immunoassays span all major disease categories, including chemistry, proteins, oncology, infectious diseases, anemia, cardiology and 20 user-defined chemistry channels.

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Immunoassay Analyzer
ASTUTE140 Meter

The ASTUTE140 Meter is an in vitro diagnostic platform that uses a sandwich immunoassay technique along with fluorescence detection technology to quantitatively measure novel biomarker concentrations of acute medical conditions and displays the test results on its LCD screen. Multiple quality control procedures ensure accurate results, which can then be printed or sent electronically to the laboratory information system (LIS).

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AKI Biomarker Assay
NEPHROCHECK Test

The NEPHROCHECK Test is a single-use cartridge designed for use on the VITROS line of automated, high-volume testing platforms to detect biomarkers of moderate to severe Acute Kidney Injury risk (AKI). It tests for two novel biomarkers (TIMP-2 and IGFBP-7) involved in G1 cell cycle arrest during the very early phases of cellular stress and are robust measures of moderate to severe risk for AKI manifesting within the next 12–24 hours.

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Integrated System
VITROS XT 7600

The VITROS XT 7600 integrated system combines Ortho's proprietary dry slide technology with sophisticated digital imaging capabilities and the potential to perform two separate lab tests simultaneously. It delivers even more enhanced, high-quality test results, higher throughput and an improved patient experience, all within the lab's existing physical footprint.

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Immunoassay Test
Sofia Lyme FIA

The Sofia Lyme Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to provide rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with either the Sofia or Sofia 2 analyzer and provides automated and objective results in 10 minutes, allowing Lyme testing to be performed in near-patient testing environments.

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Risk Assessment Tool
VITROS NephroCheck

The VITROS NephroCheck test is the first fully automated risk assessment tool for predicting Acute Kidney Injury (AKI). The simple urine test has received CE Mark clearance, provides lab results in 16 minutes, and can run on VITROS 3600/5600 immunodiagnostic systems.

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Chemistry Analyzer
VITROS 350

The VITROS 350 is a compact chemistry system with unique sample processing capabilities, including single-use disposable tips, bubble and clot detection. It helps achieve fewer repeats, redraws, and dilutions than with traditional liquid systems, and is designed to be efficient, dependable, and easy to use as a primary, STAT, or backup system.

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Blood Testing System
ORTHO Workstation

The ORTHO Workstation is the only compact 2-in-1 blood testing system with reliable ID-Micro Typing System (ID-MTS) Gel Column Agglutination Technology engineered to ensure accuracy. It uses proven reliable ID-MTS Gel Cards to offer clear, stable, well-defined end points, objective interpretation of results, and a full assay portfolio.

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Immunoassay Analyzer
Sofia 2

The Sofia 2 is a small bench top immunoassay analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source to collect hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. It uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to deliver objective and reliable results.

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Immunoassay Test
Sofia Influenza A+B FIA

The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens. Using Advance Result Technology (ART), it delivers accurate, objective and automated results in as few as three minutes.

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Auto Hematology Analyzer
ORTHO VISION Max

The ORTHO VISION Max is a fully-automated blood analyzer for high-volume transfusion medicine laboratories and also supports more complex immunohematology testing such as serial dilutions for titration studies, reflex tests and selected cell antibody identification. Its flexibility and responsiveness allows processing of routine samples and STAT orders as they are received, making it ideal for labs conducting greater than 50 types and screens per day.

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Real-Time PCR
QuantStudio Dx

The QuantStudio Dx real-time PCR instrument enables the creation of new assays in 96-well plates in IVD mode, while qPCR Microfluidic card formats provide easily interchangeable thermal cycling blocks to accommodate throughput assay development. A simplified instrument and assay workflow as well as intuitive software makes the entire test—from processing to reporting—efficient and cost-effective.

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Real-Time PCR
Applied Biosystems 7500 Fast Dx

The Applied Biosystems 7500 Fast Dx is a 96-well, five-color real-time PCR instrument for in vitro diagnostic use based on a proven platform in a plate-based format to allow for multi-well multiplexing. It features intuitive software that offers the flexibility to develop assays and also run pre-optimized protocols for users operating in a secure environment.

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Immunodiagnostic System
VITROS ECiQ

The VITROS ECiQ immunodiagnostic system verifies and documents each step throughout processing, reduces analytical errors, and provides real-time status on the quality of every patient result. It offers features such as unique short sample, clot, and bubble detection for greater security, while single-use disposable tips eliminate sample carryover and cross contamination.

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Immunoassay Analyzer
VITROS 3600

The VITROS 3600 System is built to handle peak testing workloads and maximize turnaround and system walk-away times, while reducing error potential and increasing result quality with self-monitoring VITROS technologies. It offers more than 40 world-class immunoassays across all the major disease states including cardiac, prenatal, infectious disease, oncology, anemia and more.

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Chemistry Analyzer
VITROS 4600

The VITROS 4600 Chemistry System eliminates carryover by using disposable, single-use tip design and improves result evaluation and trending ability within peer groups with configurable assay ranges that account for seven demographic attributes for greater specificity. It covers assays across a range of disease areas, including chemistry, metabolic, proteins, diabetes and immunosuppressants.

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Immunoassay Analyzer
VITROS 5600

The VITROS 5600 integrated system combines five proven technologies to remove obstacles for reducing turnaround time and providing meaningful results. Its broad menu of quality assays covers 90% of the menu needs and 99% of the testing volume for typical labs, with over 120 state-of-the-art assays across a broad range of disease areas.

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Hematology Analyzer
ORTHO VISION Analyzer

The ORTHO VISION Analyzer automates the full range of immunohematology testing including serial dilutions for titration studies and selected cell panels, which helps to eliminate manual testing, including specialty testing. Apart from an extensive menu of tests, it also provides responsive safety checks and balances to give blood bankers the ability to monitor every critical step in the automation process.

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Molecular Testing Platform
Solana

The Solana combines Quidel’s Helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results. It can test a single specimen or batch up to 12 tests at a time, and offers an intuitive, touch screen interface with guided operation and customizable settings.

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Immunoassay Analyzer
Sofia

The Sofia benchtop analyzer offers flexible workflow options, security features, and digital/LIS capabilities. Key benefits include enhanced data management, guided user interface, easy-to-use barcode scanner, walk-away automation, and greater stability and sensitivity.

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PlGF Test
Quidel Triage PlGF Test

The Quidel Triage PlGF Test is intended for the diagnosis of preterm pre-eclampsia and as an aid in the prognosis of delivery, in women presenting with signs and symptoms of pre-eclampsia after 20 weeks and before 35 weeks of gestation. It quickly, economically, and effectively identifies placental dysfunction as a root cause of preterm pre-eclampsia and is used in conjunction with other clinical information.

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Troponin I Test
Quidel TriageTrue High Sensitivity Troponin I Test

The Quidel TriageTrue High Sensitivity Troponin I Test is a fluorescence immunoassay that provides quantitative determination of Troponin I in EDTA anticoagulated whole blood and plasma specimens. It runs on the Quidel Triage MeterPro and can be used as an aid in the diagnosis of myocardial infarction.

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POC Cardiac Panel
Quidel Triage

The Quidel Triage cardiac panel is a rapid, point-of-care fluorescence immunoassay designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. It is used with the Quidel Triage MeterPro and can be used as an aid in the diagnosis of myocardial infarction (injury).

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Strep A Test
QuickVue Dipstick Strep A Test

The QuickVue Dipstick Strep A Test is a rapid diagnostic tool for detecting group A streptococcal antigen in throat swab specimens. This test provides results in just 5 minutes, offering high sensitivity and specificity for identifying streptococcal infections. The included internal and external controls ensure the reliability of results, while the simple procedure and clear illustrations make it easy for laboratory personnel to perform the test accurately. It is an essential tool for diagnosing strep throat in clinical settings.

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Troponin I Test
Quidel Triage Troponin I Test

The Quidel Triage Troponin I Test is a next-generation fluorescence immunoassay used with the Triage MeterPro for quantitative detection of cardiac troponin I. It provides sensitive and specific results to aid in the diagnosis of myocardial infarction. With fast turnaround time and point-of-care convenience, this assay enhances emergency cardiac care by allowing early detection and risk assessment of acute coronary syndromes. Its compact format makes it ideal for urgent and outpatient settings.

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Troponin I & BNP Test
Quidel Triage Cardio2 Panel

The Quidel Triage Cardio2 Panel is a fluorescence immunoassay designed for use with the portable Triage MeterPro system. It provides quantitative measurements of next-generation troponin I and B-type natriuretic peptide (BNP), critical biomarkers for diagnosing acute coronary syndromes and heart failure. This point-of-care test enables rapid risk stratification and timely clinical decision-making, especially in emergency settings. It offers high sensitivity, accurate quantification, and supports efficient patient triage and cardiac event evaluation.

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D-Dimer Test
Quidel Triage D-Dimer Test

The Quidel Triage D-Dimer Test is a rapid, quantitative fluorescence immunoassay used to assess patients with suspected thromboembolic conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). Designed for use with the Quidel Triage MeterPro, the test provides fast and accurate results at the point of care. It supports early decision-making and aids in ruling out serious clotting conditions in emergency and acute care settings.

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hCG Urine Test
QuickVue hCG Urine Test

The QuickVue hCG Urine Test is a rapid immunoassay for detecting human chorionic gonadotropin (hCG) in urine. With results available in just 3 minutes and a sensitivity of 25 mIU/mL, it offers accurate and early pregnancy detection.

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hCG Test
QuickVue+ hCG Combo Test

The QuickVue+ hCG Combo Test is a rapid immunoassay for detecting hCG in serum or urine, aiding early pregnancy diagnosis. It delivers results within 3–5 minutes, offering high sensitivity and ease of use for clinical and point-of-care settings.

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Group A Streptococcal Antigen Test
QuickVue In-Line Strep A Test

The QuickVue In-Line Strep A test uses a unique in-line extraction to detect group A streptococcal antigen directly from patient throat swab specimens. This is a true one–step test and is the first rapid strep A test waived under CLIA '88 with its two–color results giving clear readability and proven accuracy for dependable results.

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