Assays by Diseases and Conditions

Cardiac Assays

Cardiac Troponin

Troponin

Preferred Biomarker of Cardiac Injury
Troponin is a complex of three contractile regulatory proteins, troponin C, T and I, that control the calcium mediated interactions between actin and myosin in cardiac and skeletal muscles.

  • Troponin I and T are specific to cardiac muscles, unlike troponin C which is associated with both cardiac and skeletal muscles.

  • Troponin C is not used in the diagnosis of myocardial damage.

  • Both Troponin I and Troponin T are released into circulation at the time of injury following the same release pattern in the system. However, cardiac Troponin I is slightly more differentiated from skeletal Troponin I than cardiac Troponin T is from skeletal Troponin T.


Cardiac troponins are released into circulation in response to myocardial necrosis. As such, cardiac troponins are the preferred biomarkers for the detection of cardiac injury, and have long assisted physicians in improving diagnostic strategies for the effective management of patients with chest pain.

  • Relatively non-specific markers of myocardial damage, such as creatine kinase (CK), creatine kinase-MB (CK-MB), and myoglobin (MYO), were used in diagnostic laboratories prior to the commercial release of the troponin assays.

  • Numerous clinical studies on troponin have indicated its superior cardiac specificity in comparison to CK, CK-MB, or MYO.

  • Troponin levels remain elevated in the blood longer than CK-MB or MYO, providing an extended diagnostic window for MI. 

High-Sensitivity Troponin I

High-Sensitivity Troponin I is the latest addition to Siemens Healthineers’ comprehensive cardiac menu to assist clinicians with the diagnosis and treatment of chest pain patients. Designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma, high-sensitivity troponin plays a critical role in the timely diagnosis of AMI, or heart attacks.

High-sensitivity Troponin I is now available on the Atellica® IM Analyzer, ADVIA Centaur® Immunoassay System, Dimension® EXL™* and Dimension Vista® Integrated Systems.

  • Offers improved patient care with a high-sensitivity cardiac troponin assay that meets current guideline recommendations.

  • Allows you to measure slight, yet critical, changes between serial troponin I values, giving you confidence in patient results at the low end of the assay range.

  • Delivers reliable results from proven, trusted technology coupled with three new monoclonal antibodies.


Compared to traditional troponin assays, the Siemens Healthineers Atellica IM,  ADVIA Centaur, Dimension EXL and Dimension Vista TNIH assays are able to detect lower levels of troponin and smaller changes to a patient’s troponin levels, which may be an early indication of AMI. This design affords clinicians greater confidence in patient results at the low end of the assay range by delivering precision that provides the ability to measure slight, yet critical, changes between serial troponin I values.

Precision at the low end is important to minimize analytic variation that could confuse a clinician’s assessment of a clinically significant change. With this data in hand, clinicians have the ability to more quickly diagnose and treat patients with suspected AMI, in some cases in as little as one to three hours.

 

Cardiac Assay Menu

 https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/cardiac-assays/cvd-assay-menu

Natriuretic Peptides

Heart failure remains one of the most challenging medical conditions to manage, with high morbidity and mortality rates in those diagnosed with the syndrome. Natriuretic peptides (NPs) play a key and cost-effective role in the diagnosis of congestive heart failure (CHF).

NPs are markers of hemodynamic stress on the heart, denoting the neurohumoral activation of the myocardium. BNP and NT-proBNP are produced in a 1:1 ratio when the left ventricle is stretched due to hemodynamic pressure. Elevated levels of either of these peptides are associated with heart failure, and both are equally useful as an aid in the diagnosis of CHF.

Reliable Answers to Critical Cardiac Questions

As a recognized worldwide leader in CVD testing, Siemens Healthineers was the first company to offer a choice in natriuretic peptide testing, giving clinicians the power to choose:

  • Multiple instrument options for NP testing

  • Central laboratory and point-of-care testing solutions

  • Offers both BNP and NT-proBNP* on the Atellica Solution and ADVIA Centaur® Systems
     

Features

  • Excellent precision (<5% CV for both assays)

  • Provides confidence in the safe rule out of heart failure and patient risk stratification

  • Delivers reliable results from a proven, trusted technology

Infectious Disease

SARS-CoV-2 IgG Assay

Rapid and accurate antibody testing on a large scale is key to address the challenges of the COVID-19 pandemic. Over time, the SARS-CoV-2 IgG antibodies remain the primary present antibody.

The Siemens Healthineers SARS-CoV-2 IgG (COV2G) Assay* provides a semi-quantitative result to help clinicians assess the level of an individual‘s immune response.

The Science

Accurate identification of immune response to support long term COVID-19 management

The COV2G assay provides a qualitative (negative/positive) and semi-quantitative (index value) result that enables clinicians to detect the level of IgG antibodies in a patient’s blood sample and assess relative changes over time.

The addition of a semi-quantitative IgG result is an important step in the global pursuit to establish an individual’s immunity. With this numerical value, clinicians will have a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus.

Why Specificity Matters
High specificity is crucial for an accurate antibody assay. The Centers for Disease Control and Prevention guidelines for COVID-19 antibody testing states, “choosing a test with a very high specificity, perhaps 99.5% or greater, will yield a high positive predictive value in populations tested with prevalence >5%.”1 There are numerous tests that claim to detect antibodies to the virus, but only a small percentage have been shown to be highly accurate.

SARS-CoV-2 IgG Assay Specificity

  • Atellica IM: 99.95%

  • ADVIA Centaur XP/XPT: 99.89%

Thyroid

IMMULITE 2000/2000 XPi TSI Assay

Graves’ disease (GD) is an autoimmune disorder caused by the presence of thyroid stimulating immunoglobulins (TSI) that bind to the TSH receptor on the thyroid cells and stimulate the uncontrolled production of thyroid hormones. Detecting the presence of TSI in the blood is a powerful diagnostic tool for the differential diagnosis of GD.​


TSI measurements are also used to monitor the response to GD therapy and prediction of remission or relapse, confirming Graves’ ophthalmopathy, and for predicting neonatal thyroid hyperthyroidism.1,2 Incorporating the TSI assay into existing diagnostic algorithms has been shown to reduce overall direct costs of GD diagnosis by up to 43%, with the net cost of avoiding misdiagnosis reduced by up to 85%.

The IMMULITE® 2000/2000 XPi TSI assay is the first automated and quantitative TSI assay available today. TSH receptor antibody (TRAb) assays detect both thyroid blocking and stimulating antibodies. However, blocking antibodies inhibit TSH stimulation of thyroid cells and lead to hypothyroidism. The IMMULITE 2000/2000 XPi TSI assay detects thyroid stimulating antibodies, the specific cause of GD pathology, with a clinical sensitivity and specificity of 98.6% and 98.5% respectively. With a 65-minute total assay time and ready-to-use, stable reagents, the use of this assay can make the differential diagnosis of GD faster and easier, allowing patients to be diagnosed and treated sooner.

 

 

Thyroid Assay Menu 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/thyroid-assays/thyroid-assay-menu

Liver Fibrosis Assays

Enhanced Liver Fibrosis (ELF™) Test

Non-alcoholic fatty liver disease (NAFLD) impacts over 1 billion globally and is projected to become the leading cause of liver-related mortality within 20 years.1 As new therapies become available, non-invasive testing is an important tool to help identify patients at risk of developing cirrhosis and liver-related clinical events (LREs).

NAFLD: A Global Epidemic

NAFLD is a condition in which excess fat is stored in the liver. The buildup of fat that is not caused by heavy alcohol use.

  • There are two types of NAFLD: simple fatty liver (simple steatosis) and non-alcoholic steatohepatitis (NASH).

  • Comorbidities such as obesity, and type 2 diabetes are associated with NAFLD.

  • NAFLD is predicted to be the leading indication for liver transplantation within a decade.

Current Challenges in NAFLD Patients

  • Differentiating NASH from simple steatosis (risk-stratification) and identifying NASH patients with advanced fibrosis.

  • Despite being the gold standard for diagnosing liver fibrosis, liver biopsy is a painful and invasive procedure associated with inter- and intra-observer variability, and sampling error, which may make it impractical to use in every patient.4,5,6

  • Currently, there is no available liver fibrosis test that is convenient, objective, reproducible, and widely accessible to all relevant healthcare practitioners.

The ELF Test

The ELF test is a non-invasive blood test that measures three direct markers of fibrosis: hyaluronic acid (HA), procollagen III amino-terminal peptide (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The ELF test, in conjunction with other laboratory and clinical findings, can be used to assess the risk of progression to cirrhosis and LREs in patients with chronic liver disease.

  • Access non-invasive testing with a simple blood test available to all healthcare practitioners and patients, including those with type 2 diabetes mellitus and obesity.

  • Improve patient care by identifying NAFLD patients and stratifying those at risk of progressing to cirrhosis and LREs.

  • Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.

Liver Fibrosis Assay Menu

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/liver-disease/what-is-liver-fibrosis

Bone Metabolism

Vitamin D

Vitamin D is a fat-soluble hormone involved in the intestinal absorption of calcium and regulation of calcium. It plays a vital role in the formation and maintenance of strong, healthy bones. Vitamin D deficiency has long been associated with rickets in children and osteomalacia in adults, and long-term insufficiency of calcium and vitamin D leads to osteoporosis. However, in recent years, vitamin D levels has become known as an indicator of general health status, and there have been multiple publications linking insufficient levels of vitamin D to several disease states, such as cancer, cardiovascular, diabetes, and autoimmune diseases.

Vitamin D Deficiency

Worldwide, an estimated 1 billion people have inadequate levels of vitamin D in their blood, and deficiencies can be found in all ethnicities and age groups. Vitamin D deficiency rates have increased as people have limited their sun exposure due to the risk of skin cancer. People living near the equator who are exposed to sunlight without sun protection have robust levels of vitamin D; however, vitamin D deficiency is found in regions where skin exposure is limited and where sun protection is promoted to avoid UV injury to skin.

Groups at Higher Risk for Vitamin D Deficiency

There are several groups at higher risk of vitamin D deficiency including:

  • Breastfed Infants: Sufficiency is dependent on the mother’s vitamin D sufficiency level. Mother's milk typically contains about 25 IU/L of vitamin D.

  • Older Adults: As people age, the skin is not able to synthesize vitamin D as effectively, and reduced kidney function impacts the ability to convert vitamin D.

  • Dark Skinned People: Melanin in darker skin reduces the ability to produce vitamin D from sunlight exposure.

  • Limited Sun Exposure: Eliminates one of the two possible sources of vitamin D.

  • Obesity: Vitamin D is fat soluble, which does not allow it to circulate as freely.

  • Other: Gastric bypass patients have less small intestine available to absorb vitamin D.

Vitamin D Total Assay 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/bone-metabolism-assays/vit-d-total-assay

Bone Metabolism Assays 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/bone-metabolism-assays/bone-metabolism

Intact PTH Assay

Measurements of Intact PTH (iPTH) are used in the assessment of iPTH status in many clinical conditions, including the differential diagnosis of hyperparathyroidism or hypothyroidism. Intact PTH levels are also used to assess and manage other metabolic bone disorders, including osteoporosis and renal osteodystrophy.

  • Enhances calcium absorption in the intestines by stimulating the renal synthesis of 1,25(OH)2vitamin D

  • Increases the amount of calcium in the blood through the release of PTH and the removal of calcium from the bone

  • Decreases the amount of calcium by releasing less PTH

Siemens Healthineers' iPTH assays utilize a high-quantum-yield molecule, which reduces non-specific binding, improves sensitivity and precision, requires smaller sample volume, and provides better onboard stability and longer shelf life for reagents.

  • Preformed design minimizes biotin interference (biotin levels tested up to 1000 ng/mL), ensuring confidence in patient results

  • Assay design with monoclonal antibodies and kitted calibrators ensure reduced lot-to-lot variation

  • Minimal cross-reactivity increases accuracy in iPTH results, especially in patients undergoing biotin treatment

  • Intra-operative claim to assess parathyroid excision provides important guidance to surgeons in assessing surgical procedures

Siemens Healthineers offers iPTH assays on the Atellica IMADVIA Centaur, and IMMULITE System

Sepsis & Inflammation

Sepsis and the B·R·A·H·M·S Procalcitonin (PCT) Assay

Sepsis is a leading cause of death in hospitals worldwide, placing a significant health and economic burden on both patients and healthcare institutions. An early and accurate diagnosis can save precious time, expense, and most importantly, lives. The Siemens Healthineers B·R·A·H·M·S Procalcitonin (PCT) Assay can aid healthcare providers in the diagnosis of sepsis. 

Sepsis is a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.1 If not recognized and treated quickly with appropriate antibiotics and supportive measures, sepsis can rapidly evolve into septic shock.

  • Approximately 25% of patients with sepsis will develop septic shock, and up to 80% of patients with septic shock will die.

What is PCT?

  • When bacterial infection is present, PCT is released from virtually every type of organ and tissue in the body.

  • Increasing serum PCT concentrations indicate increased severity of infection and a worse prognosis for the patient.

Siemens Healthineers B·R·A·H·M·S PCT Assay

There is a definite clinical need for earlier detection of sepsis. When seconds count, accurate results can make the difference between life and death.

Challenges

  • Identifying patients with sepsis early, when treatment is most likely to be effective.

  • Knowing if the antibiotics applied are appropriate and effective.

  • Predicting which patients are at the greatest risk of a poor outcome and require closer monitoring and care.

  • Reducing high costs associated with treating patients with severe sepsis and septic shock.

  • Differentiating sepsis from other inflammatory diseases, trauma, and other conditions whose clinical picture (signs, symptoms, and laboratory findings) is similar to sepsis.

  • Reducing unnecessary antibiotic use and its associated costs and side effects.

Solution: The Atellica® IM B·R·A·H·M·S PCT Assay

  • Helps achieve early sepsis risk assessment to help improve patient outcomes, including reduced morbidity and mortality with the ability to make confident decisions in minutes.

  • Gain confidence when guiding antibiotic therapy with an assay that has optimal precision across the measurable range.

  • Deliver reliable results from a proven, trusted technology that demonstrates high agreement with the B·R·A·H·M·S PCT sensitive KRYPTOR assay.

I

Inflammation & Infection Test Solutions

Inflammation is a vital part of the body’s immune response. The function of inflammation is to destroy and remove pathogens. If destruction is not possible, inflammation limits effects by confining the pathogen and its products. It is also important for repairing and replacing tissue damaged by the pathogen and its products. Inflammation can potentially be a harmful process. Components of inflammation that are capable of destroying microbes can also injure bystander normal tissue. There are two types of inflammation, acute and chronic.

Interleukin-6 (IL-6)

Interleukin-6 (IL-6) is an early indicator of inflammatory response to illness or injury. IL-6 rises within hours of substantial injury or infection and can be monitored to reveal if a patient is suffering an acute response to surgery, trauma, or infection and if the response is waning slowly or rapidly, which can help to predict the patient’s risks and prognosis.

ADVIA Centaur IL6 Assay Benefits

  • Assists physicians in the evaluation of a variety of acute and chronic diseases associated with inflammation such as sepsis, neoplastic disorders, autoimmune diseases, AIDS, alcoholic liver disease, and infections or transplant rejection.

  • Predict infection at the onset of a new fever before microbiological culture results are available.

  • Gain workflow efficiency in your sepsis and inflammation testing with a rapid turnaround time.

Lipopolysaccharide- binding Protein

Lipopolysaccharide-binding protein (LBP) aids in the diagnosis and prognosis of diseases induced by exposure to endotoxin, such as sepsis and infectious complications of surgery and trauma. LBP has been shown to be elevated in patients with gram negative, gram positive, and fungal infections.

IMMULITE LBP Assay Benefits

  • Achieve detection of LBP levels above the normal reference level that have been reported in patients with severe local infection, a systemic bacterial or fungal infection, or septicemia.

  • Predict severity of lung injury and mortality in patients with severe sepsis.

  • Gain workflow efficiency in your sepsis and inflammation testing with rapid turnaround time.

Assay Menu

 https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/sepsis-and-inflammation/inflammation-infection-test-solutions

Reproductive Endocrinology

Infertility and Pregnancy

Siemens Healthineers offers a complete solution with every assay required in a fertility portfolio. Patients can get results quickly and take appropriate action, therefore increasing the chances of a successful pregnancy.

  • Aids in identifying the complex causes of infertility for appropriate treatment.

  • Provides assays designed for clinical diagnostic accuracy, offering wide analytical measuring ranges with good precision and rapid turnaround time.

  • Reduces hands-on labor and improves workflow efficiency and turnaround time with fully automated assays.

Infertility

Infertility is defined as the inability to achieve conception after one year of unprotected intercourse, or the inability to maintain a viable pregnancy until birth.

Siemens Healthineers Assays for the Evaluation of Women’s Infertility
AMH
Androstenedione
DHEAS
Estradiol
FSH
LH
Progesterone
Prolactin
SHBG
Testosterone II
TSH

Siemens Healthineers Assays for the Evaluation of Men’s Infertility
Androstenedione
DHEAS
Estradiol
FSH
LH
Prolactin
SHBG
Testosterone II

Pregnancy

During pregnancy, a fascinating transformation takes place in the body not only anatomically, but biochemically as well. It is critical to have the proper menu to identify infertility, improve likelihood of conception, and promote a successful birth.

Siemens Healthineers Assays for the First Trimester
HCG
Progesterone
Free ß-HCG
PAPP-A

Siemens Healthineers Assays for the Second Trimester
AFP
HCG
Unconjugated Estriol

Siemens Healthineers Assays for the Third Trimester
PIGF
sFLT-1
Unconjugated Estriol

Reproductive Endocrinology Assay Menu

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/reproductive-endocrinology/assays

Diabetes

Diabetes Overview and Testing

Around the world, an estimated 425 million adults have diabetes. By 2040, this number will rise to over 640 million.

As diabetes across the globe continues to rise, so must the effort to raise awareness. 37% of all diabetic adults live in the Asia-Pacific region. In Africa, more than two-thirds of people with diabetes are undiagnosed. In Latin America, the number of people with diabetes will increase by 65% by 2040.1 And in 2012, treating diabetes and its related conditions cost Americans about $245 billion in total medical costs and lost work and wages.

Many of those who are undiagnosed may have or be at risk of prediabetes, and recent research has shown that some long-term damage to the body, especially the heart and circulatory system, may already occur in prediabetics.

 

Monitoring the Condition

Those diagnosed with diabetes are encouraged to monitor their condition on a regular basis. By measuring hemoglobin A1c (HbA1c), doctors can gauge your average blood sugar levels from the last 2-3 months and thereby provide a more tailored treatment plan. HbA1c measurement can also show whether treatment plans and lifestyle choices have been effective.

Type 1 Diabetes

  • Formerly called “insulin-dependent” or “juvenile-onset” diabetes

  • An autoimmune disease that causes destruction of pancreatic beta cells, which are responsible for synthesizing and secreting insulin

  • Accounts for 5 to 10 percent of all diabetics

Type 2 Diabetes

  • Formerly called “non-insulin-dependent” or “adult-onset” diabetes

  • Caused by insulin resistance or inadequate insulin secretion

  • Accounts for 90 to 95 percent of diabetes in developed countries

Pre-diabetes

  • Patients with Impaired Glucose Tolerance and Impaired Fasting Glucose

  • Individuals have blood glucose levels higher than normal but not high enough to be classified as diabetes

  • People with pre-diabetes have an increased risk of developing type 2 diabetes, heart disease, and stroke

Siemens Healthineers offers a wide range of diabetes-related assays that aid in the differentiation of type 1 from type 2 diabetes, help to monitor glycemic control, and allow doctors to follow the progression of the disease through HbA1c monitoring.

Diabetes Assays 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/diabetes/diabetes-assays

Oncology

Breast Cancer

Serum HER-2/neu, BR 27.29, and CA 15-3 Assays

Breast cancer is the most common cancer among women. Breast cancer survival rates have increased, and the number of deaths associated with this disease is steadily declining, largely due to factors such as earlier detection and a better understanding of the disease.

BR 27.29 and CA 15-3 Assays

The Siemens Healthineers BR 27.29 and CA 15-3 assays are intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The BR 27.29 and CA 15-3 assays aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Siemens Healthineers BR 27.29 and CA 15-3 Assay Benefits

  • Achieve early detection of breast cancer to aid in monitoring disease recurrence.

  • Improve patient management by using an assay to detect circulating tumor markers, such as CA 27.29 and CA 15‑3, which can monitor response to therapy and can indicate disease status.

  • Gain lab efficiency by consolidating oncology testing onto one trusted system.

BR 27.29 system availability: Atellica® IM Analyzer and ADVIA Centaur® CP/ XP/XPT Immunoassay Systems.
CA 15-3 system availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.

Serum HER-2/neu Assay

Studies have shown that up to 90% of metastatic breast cancer patients can have an elevated Serum HER-2/neu level. In HER-2/neu positive breast cancer, the cancer cells have an abnormal level of HER-2/neu genes per cell, which leads to abnormally high levels of the HER-2/neu cancer-causing proteins called oncoproteins (overexpression).

Siemens Healthineers offers the HER-2/neu assay for measurement of circulating levels of the HER-2/neu oncoprotein in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu is greater than 15 ng/mL. Monitoring Serum HER-2/neu levels yields important information about response to therapy, and may help physicians make more informed decisions when developing and modifying patient treatment regimens.

Siemens Healthineers Serum HER-2/neu Assay Benefits

  • Gain confidence in testing with a reliable and easily interpreted assay that has good precision and resistance to interference from HER-2/neu-based therapy.

  • Enhance clinical reporting with a broad assay range of 0.5 - 350 ng/mL.

  • Improve long-term patient monitoring due to low reagent lot-to-lot variability.


 

Prostate Cancer

A Comprehensive Portfolio of PSA Assays

Prostate cancer is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall. There were 1.3 million new cases of prostate cancer in 2018.1 Siemens Healthineers offers a full menu of Prostate Specific Antigen (PSA) tests that aid in the detection, monitoring and management of prostate cancer. In addition to traditional PSA tests, the Siemens Healthineers portfolio includes the unique Complexed PSA assay that is an alternative to conventional testing and can improve the detection of clinically significant cancers.

PSA Assays

PSA testing is a classic screening method to aid in the detection of prostate cancer and is clinically accepted by the NACB and EGTM for both detection and monitoring. Siemens Healthineers offers the following PSA assays:

PSA Assay: Intended for the measurement of serum PSA, in conjunction with a digital rectal exam (DRE), as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.

Free PSA (fPSA) Assay: Intended to be used in conjunction with the Atellica® IM PSA Assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and a digital rectal exam (DRE) non‑suspicious for cancer to determine the percent free PSA value. The percent free PSA value can be used as an aid in discriminating between prostate cancer and benign prostatic disease.

Complexed PSA (cPSA) Assay: Intended for the measurement of serum‑complexed PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. PSA complexed with alpha-1-antichymotrypsin (ACT) comprises a higher proportion of PSA in men with prostate cancer.This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.

Siemens Healthineers PSA Assay Benefits

  • Reduce unnecessary biopsies by using an assay that helps to discriminate between prostate cancer and benign prostatic diseases.

  • Achieve accurate results with improved specificity in the detection of prostate cancer.

  • Improve patient management with information on possible disease relapse.

Other Cancers

Colorectal Cancer Testing

Carcinoembryonic Antigen (CEA) Assay


CEA belongs to a group of tumor markers referred to as oncofetal proteins. Increased serum CEA levels have been detected in persons with primary colorectal cancer and in patients with other malignancies including gastrointestinal tract, breast, lung, ovarian, prostatic, liver, and pancreatic cancers.
Siemens Healthineers offers the Carcinoembryonic Antigen (CEA) assay for in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed.

Siemens Healthineers CEA Assay Benefits

  • Improve patient management with information about patient prognosis, recurrence of tumors after surgical removal, and effectiveness of therapy.

  • Consolidate oncology testing on one trusted system for increased efficiency.

System availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.

Ovarian Cancer Testing

CA 125II™ Assay
Siemens Healthineers CA 125II™ assay is for in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Siemens Healthineers CA 125II Assay Benefits

  • Improve patient management with a useful tumor marker for evaluating therapy and monitoring disease status in patients under treatment for ovarian cancer.

  • Detect cancer recurrence early with a prognostic indicator of clinical outcome.

  • Consolidate oncology testing on one trusted system for increased efficiency.

System availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.

Pancreatic Cancer Testing

CA 19-9 Assay
The Siemens Healthineers CA 19-9 assay is intended for use as an aid in monitoring patients previously treated for GI cancer. Serial testing for CA 19‑9 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of GI cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Siemens Healthineers CA 19-9 Assay Benefits

  • Gain a test that is a more sensitive and specific marker of pancreatic cancer compared to other serologic markers.

  • Achieve accurate results by utilizing the single most useful blood test in differentiating benign from malignant pancreatic disorders.

  • Consolidate oncology testing on one trusted system for increased efficiency.

System availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.

Testicular Cancer Testing

AFP Assay
The Siemens Healthineers AFP assay is for the quantitative determination of alpha-fetoprotein in human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.

Siemens Healthineers AFP Assay Benefits

  • Achieve good sensitivity with an established regimen for monitoring patients with non-seminomatous testicular cancer.

  • Consolidate oncology testing on one trusted system for increased efficiency.

System availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.

Thyroid Cancer Testing

Calcitonin Assay
The Siemens Healthineers Calcitonin (CALCT) Assay can be used as an aid in the diagnosis of medullary thyroid carcinoma (MTC), and to monitor the effectiveness of therapy and disease progression in patients with calcitonin-producing tumors in conjunction with other clinical and laboratory findings.

Siemens Healthineers Calcitonin Assay Benefits

  • Achieve accurate results with a calcitonin assay that has good precision across the range of the assay.

  • Delivers low-end sensitivity to monitor the effectiveness of therapy.

  • Eliminates high-dose hook effect up to 1,200,000 pg/mL (351,120 pmol/L), providing confidence in results.

System availability: Atellica® IM Analyzer, ADVIA Centaur® XP/XPT Immunoassay Systems and IMMULITE® 2000/2000 XPi Immunoassay System.

Oncology Assay Menu

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/laboratory-diagnostics-in-oncology/siemens-offerings

Drugs of Abuse Assays

Comprehensive drug-testing solutions

Drug abuse and addiction are top public-health concerns with negative consequences for individuals and society. This worldwide epidemic is responsible for tremendous costs and health, social, and community impacts.

Siemens Healthineers has been a pioneer in drugs-of-abuse testing (DAT), and for over 50 years has helped nurture and expand the industry by striving to deliver assays that meet the latest innovations to help your lab increase efficiency, control costs, consolidate workflow, and improve the effectiveness of drug-testing programs.

Assay Menu 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/drugs-of-abuse-assays/expanded-drug-testing-menu

ARK™ Fentanyl Assay for Siemens Healthineers Chemistry Systems

The U.S. Centers for Disease Control and Prevention describes fentanyl as a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. The potency of fentanyl and the alarming increase of misuse and abuse poses an overdose danger, often unintentional.

Because fentanyl is so strong, the difference between a dose that will get you high and a dose that can kill you is very small.

The ARK Fentanyl assay is now available as an Alliance Application on Siemens Healthineers chemistry systems including the Atellica® CH Analyzer. It measures fentanyl in human urine.

  • Fentanyl is a synthetic opioid similar to morphine, prescribed for patients with chronic pain, post-operative pain, or treatment of breakthrough pain in cancer patients.

  • The ARK Fentanyl assay demonstrates cross-reactivity with norfentanyl.

  • Detecting norfentanyl is clinically important due to the quick metabolization of fentanyl into norfentanyl, its major metabolite.

Benefits

  • Gain more confidence in your results with the ARK Fentanyl assay that demonstrates cross-reactivity with norfentanyl (a major metabolite).

  • Save valuable time by eliminating the need to send out fentanyl screens or waste time confirming false positives.

  • Streamline your opioid testing on one system and complement your drugs-of-abuse testing panel by adding this assay to your arsenal of opioid tests.

EMIT II Plus 6-Acetylmorphine Assay

The EMIT® II Plus 6-Acetylmorphine Assay accurately detects heroin use, without cross-reactivity to morphine, morphine metabolites, and many common analgesics. Siemens offers a convenient and effective way to selectively test for heroin use and enables your laboratory to adjust to changing testing requirements.

  • High specificity for 6-Acetylmorphine (6-AM)

  • No cross-reactivity to morphine, morphine metabolites, and common analgesics

  • Qualitative (10 ng/mL cut-off) and semi-quantitative results

  • Low analytical sensitivity of 1.1 ng/mL

  • >99% agreement with the reference method (GC/MS)

Features & Benefits

Maintain a high level of integrity in your drug testing program, with the addition of the Emit® II Plus 6-Acetylmorphine Assay to your current offering.

Over the past decade, the number of heroin confiscations has more than doubled.1 Furthermore, an increasing amount of morphine-type drugs are prescribed as analgesics that can cross-react with traditional opiate assays.

Can a rapid screen differentiate heroin use from prescribed or ‘over-the-counter’ medications?

The presence of the heroin metabolite 6-Acetylmorphine (6-AM) in urine specifically confirms the use of heroin. The new EMIT II Plus 6-Acetylmorphine Assay is intended for the qualitative and semi-quantitative determination of 6-AM in human urine, at a cut-off value of 10 ng/mL. This new assay meets the Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines for Federal Workplace Testing.

 

The EMIT® II Plus 6-Acetylmorphine Assay provides:

  • High specificity for 6-Acetylmorphine (6-AM)

  • No cross-reactivity to morphine, morphine metabolites, and common analgesics

  • Qualitative (10 ng/mL cut-off) and semi-quantitative results

  • Low analytical sensitivity of 1.1 ng/mL

  • >99% agreement with the reference method (GC/MS)

  • Rapid results: 11 minutes to first result

  • Convenient dual calibrator/control with the EMIT II Plus Ecstasy Assay

Applications are available for Siemens’ Viva-Jr®, Viva-E®, and V-Twin® Drug Testing Systems, the Dimension® and Dimension Vista®, as well as a variety of other general chemistry analyzers.

Emit II Plus Oxycodone Assay

The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

Oxycodone is a semisynthetic opioid analgesic prescribed for the relief of moderate to severe pain. Oxycodone structurally resembles codeine and morphine, with similar analgesic properties and potential for addiction and abuse. Oxycodone is a DEA schedule II drug. The drug oxycodone is prescribed in controlled-release form (OXYCONTIN), or in combination with acetaminophen (PERCOCET) or with aspirin (PERCODAN).

Features & Benefits

The Emit II Plus Oxycodone assay offers 100 ng/mL and 300 ng/mL cutoffs and no cross-reactivity to structurally related compounds such as buprenorphine and hydrocodone.

  • Achieve high specificity for oxycodone and oxymorphone to provide confidence for accurate results while meeting the SAMHSA requirements for oxycodone screening

  • Reduce false results with an assay that has 98% agreement to LC-MS/MS for positive samples and 100% agreement for negatives.

  • Consolidate opioid testing with other Siemens Healthineers assays, enabling providers to screen patients on one trusted system

Anemia

Atellica IM/ADVIA Centaur Active-B12 Assay

Vitamin B12 (cobalamin) plays an important role in DNA syntesis and neurologic function. Deficiency can lead to a wide spectrum of hematologic and neuropsychiatric disorders that can often be reserved by early diagnosis and prompt treatment.

The primary analysis of vitamin B12 deficiency is the measurement of serum cobalamin (vitamin B12). There commonly used tests measure total vitamin B12, which is found in blood bound to two carrier poteins: haptocorrin and transcobalamin. When vitamin B12 is bound to transcobalamin it is referred to as holotranscobalamin (holoTC). HoloTC contains the biologically available cobalamin as only holoTC promotes the uptake of cobalamin by all cells via specific receptors. In comparison, approximately 80% of the circulating cobalamin that is carried by haptocorrin is considered metabolically inert because no cellular receptors exist (with the exception of receptors found in the liver.)

The Siemens Healthineers Active-B12 (AB12) assay offered on the Atellica® IM Analyzer and ADVIA Centaur® Immunoassay Systems measures holo TC in the blood – the only form of vitamin B12 that is taken up and used by cells of the body.

What are the signs and symptoms of vitamin B12 deficiency?


Vitamin B12 deficiency associated signs and symptoms could take years to manifest in adults. Infants and children will show signs of deficiency much sooner because they have not yet had time to store sufficient amounts. People with vitamin B12 deficiency may encounter symptoms such as:

  • Anemia

  • Fatigue

  • Weakness and light-headedness

  • Shortness of breath

  • Loss of balance

  • Yellowed skin

  • Strange sensations, numbness, or tingling in the hands, legs, or feet

Who is likely to develop vitamin B12 deficiency?

  • The elderly

  • People with intestinal and/or digestive disorders

  • Heavy alcohol drinkers

  • Pregnant women.

  • Vegetarians and Vegans

Anemia Assay Menu 

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/anemia/anemia-assay

Autoimmune Disorders

Rheumatoid Arthritis

Rheumatoid arthritis, or RA, is one of the most common autoimmune diseases, affecting 1.0% of the adult world population. More than one million Americans suffer from RA. About 75% of those affected are women. Literature indicates that early detection of RA is critical to ensure that early treatment is administered to prevent the development of disabling joint erosions.

In addition to clinical evaluation involving a physical exam and discussion of symptoms, laboratory testing is performed to help diagnose rheumatoid arthritis, to distinguish it from other forms of arthritis and inflammatory conditions, and to evaluate its severity. Testing can also be used to monitor the condition, its potential complications, response to treatment, and to monitor for potential side effects associated with some treatments.

Autoimmune Assay Menu

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/autoimmune-disorders/assays

Therapeutic Drug Monitoring

Commonly Monitored Drugs

Antiepileptics

This class of drugs, also known as anticonvulsants, is most often prescribed for the management of epilepsy, though some drugs may also be prescribed for other indications such as tic douloureux, myotonia, bipolar effective disorder, prophylaxis of certain varieties of migraine and of cardiac dysrhythmia. All antiepileptic drugs are capable of depressing abnormal neuronal discharges in the central nervous system, which may otherwise result in seizures. Other drugs in this category, such as clonazepam and sulthiame, do not require monitoring.

  • Carbamazepine

  • Phenobarbital

  • Phenytoin

  • Valproic Acid

 

Antiarrhythmics

Arrhythmia is a disorder that may result in cardiac abnormalities. They are classified as either tachycardia (fast heartbeat, > 100 bpm) or bradycardia (slow heart beat, < 60 bpm). Antiarrhythmic agents are used to control the rate and rhythm of the heart beat. This class of drugs is segregated into four subclasses based on the action of the drug. Many of the drugs in class I require frequent monitoring, and are therefore being displaced by the class II and III drugs, which require less monitoring.

  • Digitoxin

  • Digoxin

  • Lidocaine

  • NAPA

  • Procainamide

 

Antibiotics

Most of the drugs in this class have wide therapeutic ranges and therefore do not require therapeutic monitoring. However, those with narrow therapeutic ranges require monitoring to avoid potentially irreversible toxicity. Still others are monitored on a case-by-case basis. Gentamicin and tobramycin are aminoglycoside antibiotics most commonly used for infections by resistant gram-negative organisms. Vancomycin is glycopeptide antibiotic used to treat life-threatening infections caused by gram-positive cocci. Due to the emergence of vancomycin-resistant organisms, it has been recommended that its use be restricted to treating methicillin-resistant Staphylococcus aureus and ampicillin-resistant enterococcal infections.

  • Gentamicin

  • Tobramycin

  • Vancomycin

 

Antimanics

Used to treat bipolar disorders or mania associated with other affective disorders.

  • Lithium

 

Bronchodilators

Theophylline is one of the most commonly used bronchodilators. It is primarily used to treat patients with chronic asthma. Monitoring is necessary due to the drug’s highly variable inter-individual pharmacokinetics.

  • Theophylline

 

Immunosuppressants

TDM testing is a critical aspect of immunosuppressive drug therapy. Optimizing drug dosing is not only key to avoiding rejection, but also in reducing the severe side effects of these drugs (infections, cancer, weight gain, hypertension, and possible liver or kidney failure), which often prompt patient non-compliance. The strategy is to employ a combination of drugs in doses that prevent acute rejection and loss of graft function without compromising overall health. Transplant patients are prescribed immunosuppressive drugs as lifelong maintenance therapy and most drugs are routinely monitored.

Therapeutic Drug Monitoring Assay Menu

https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/therapeutic-drug-monitoring/therapeutic-drug-monitoring-assay

Growth Disorders

Growth Assays

Growth hormone tests are used to help identify excess or diminished growth hormone (GH) production and provide information about the severity of a person’s condition. They are part of the diagnostic work-up required to find a cause for abnormal hormone production.

Growth Assay Menu

Growth hormone (GH), IGF-I, and IGFBP-3 results are essential when diagnosing and treating growth disorders. The Siemens GH assay is very specific and sensitive and requires only a small sample volume. Siemens IGF-I and IGFBP-3 assays have established sex-and age-based reference intervals that are crucial in assessing the patient’s growth condition.

Our 2000/XPi IGF-I assay is now standardized to the WHO 1st International Standards for IGF-I.

Growth Hormones

Growth hormone (GH) is secreted from the pituitary gland. Measurement of GH is primarily of interest in the diagnosis and treatment of various forms of inappropriate growth hormone secretion.

Too much growth hormone (hypersecretion) can cause abnormal growth patterns called acromegaly in adults and gigantism in children. Too little growth hormone (hyposecretion) can cause a slow or flat rate of growth in children, and changes in muscle mass, cholesterol levels, and bone strength in adults. Clinical disorders of hyposecretion include dwarfism and unattained growth potential.

IGF-I

In the diagnosis of growth disorders, measurements of IGF-I are a useful indicator of growth hormone secretion. A normal plasma or serum IGF-I concentration is strong evidence against GH deficiency. A low IGF-I value implies GH deficiency and requires additional testing to determine whether GH secretion is subnormal. Measurement of IGF-I is also useful in assessing change of nutritional status.
An IGF-I test is often ordered along with GH. IGF-I mirrors GH excesses and deficiencies, but its level is stable throughout the day, making it a useful indicator of average GH levels.

IGFBP-3

IGFBP-3 is used as an aid in the evaluation of growth disorders. It is growth hormone (GH) dependent and therefore useful in the evaluation of GH secretion. IGFBP-3 is the main carrier of IGF-I in the body. Blood levels of both these proteins are controlled by GH. IGFBP-3 also helps extend the life of GH in the blood and helps control its effects on body tissues.
Levels of IGFBP-3 are highest during childhood and puberty, and then decrease during adulthood. Levels may also be affected by sexual maturation and nutritional status.

Growth Disorders

Growth disorders affect thousands of people each year. A person may be diagnosed as a child or as an adult. There are different types of growth disorders, many caused by imbalances in different types of hormones.

Growth Hormone Deficiency

Growth hormone deficiency means the pituitary gland does not make enough growth hormone. Most of the time, the cause of growth hormone deficiency is unknown. It may be present at birth or develop as a result of an injury or medical condition. Severe brain injury may also cause growth hormone deficiency. Slow growth may first be noticed in infancy and continue through childhood. Although uncommon, growth hormone deficiency may also be diagnosed in adults. Possible causes include tumors involving the pituitary gland or hypothalamus, or brain radiation treatments for cancer.

Excessive Growth

 

Gigantism–Excessive action of IGF-I while epiphyseal growth plates are open causes gigantism, which occurs very rarely7. Children and adolescents with gigantism stand > 2 standard deviations above the mean height for their gender and age.

 

Acromegaly–Also caused by hypersecretion of IGF-I, acromegaly is the most common disorder of GH excess. In contrast to gigantism, it occurs in adolescence and adults after their epiphyseal growth plates have fused. The name acromegaly comes from the Greek words for “extremities”(acro) and “great”(megaly), because one of the most common symptoms of this condition is abnormal growth of the hands and feet.

The symptoms of acromegaly can vary and develop gradually over time; therefore, a diagnosis of this condition may be difficult. Early detection is a goal in the management of acromegaly because the pathologic effects of increased growth hormone (GH) production are progressive. IGF-I provides the most sensitive lab test for the diagnosis of acromegaly.

Allergy

Laboratorian Information

How 3gAllergy Liquid Allergens Testing Works

The 3gAllergy™ assay is the first third-generation assay detecting allergen-specific IgE, which aids physicians in their diagnosis and allows for early treatment. The assay delivers fast, reliable results—helping physicians identify allergies quicker. 

Siemens Healthineers proprietary liquid allergens are the key to making IMMULITE® 2000 and IMMULITE® 2000 XPi Immunoassay allergy tests sensitive, specific, and reliable. The soluble polymer/copolymer support for the allergens increases the number of binding sites and their accessibility to allergen-specific IgE antibodies. Enzyme-enhanced chemiluminescent signal detection provides increased sensitivity and the proprietary wash technique enhances specificity. 

Third-generation Sensitivity
Zero Calibrator: Another Unique Feature
Siemens’ zero calibrator provides greater sensitivity and precision at the low end of the calibration curve, ensuring a detection limit of 0.1 kU/L. 

3gAllergy Assay Products
Allergy products from Siemens Healthineers address the needs of both patients and healthcare professionals. You'll find a broad menu of allergy tests on the IMMULITE® 2000 and IMMULITE® 2000 XPi Immunoassay systems specifically designed to aid in the screening, diagnosis, and monitoring of allergy patients.

Immunoassay Tests for Specific Allergens and Panels

3gAllergy™ Universal Kit
This is the basic component of the module-based specific allergen testing procedure. With the Universal Kit, one master curve applies to all specific allergens and panels. Available on IMMULITE 2000 and IMMULITE® 2000 XPi Immunoassay system. 

Immunoassay Tests for Specific Allergens and Panels
Individual barcoded vials of a specific allergen or panel are used to determine the specific IgE in the patient samples. 3gAllergy Universal kit is required. 

An expanding allergy menu of specific allergens and allergen panels in the following categories:

  • Animals

  • Food

  • Grasses

  • House Dust

  • Insects

  • Medicines

  • Mites

  • Molds

  • Occupational

  • Parasites

  • Trees

  • Weeds

Immunoassay Tests for Initial Screening
Total IgE
The quantitative test for total IgE to confirm or exclude atopic allergy in patients. Available for use on IMMULITE®, IMMULITE 2000 and IMMULITE® 2000 XPi Immunoassay systems. 

Now you can run allergy testing alongside your routine and specialty immunoassays.

A Unique Assay
With 3gAllergy, you can centralize your allergy and other immunoassay testing onto one automated platform—and get unparalleled third-generation assay sensitivity!

  • No special equipment needed.

  • No special training required—use existing staff.

  • No reason to send out allergy tests anymore.

The 3gAllergy assay employs cutting-edge technology and third-generation precision. Some of its unique features include:

  • Liquid-phase allergens for greater sensitivity, greater specificity, and a fast turnaround time of 65 minutes

  • Enzyme-enhanced chemiluminescence for optimal accuracy


Easy-to-Use Systems
3gAllergy runs on a true walk-away, fully automated random access platform. It allows for up to 138 allergens onboard and offers:

  • No manual pipetting

  • Less hands-on time for technicians, minimizing errors and labor cost

  • High throughput for greater efficiency

  • Easy operation and proven system reliability

  • More than 480 specific allergens and allergy panels

Custom pack the allergen wedge to suit your workflow
Customize the configuration of an allergen wedge with up to six allergen vials of your choice. As many as 23 allergen wedges plus a Universal Reagent Wedge fit on each carousel.

  • Up to six interchangeable allergens per wedge

  • User-defined mix of allergens

  • Barcoded allergens to eliminate errors

  • All allergen information scanned from wedge

  • Up to 138 allergens onboard at any time

  • Stable onboard for 90 days

The use of molecular insect venom allergens can assist clinicians with:

  • Defining a more personalized and relevant sensitization profile for each patient

  • Choosing the right venom immunotherapy for the patient

  • Differentiating patients with double-sensitization to honeybee and vespid species