Plasma Proteins

Plasma Protein Systems

Atellica NEPH 630 System

Small - 72 DPI-LD_Atellica_NEPH630_Right

The Atellica® NEPH 630 System is a mid-volume dedicated nephelometric analyzer that simplifies lab operations in specialty protein testing. The system offers the broadest menu of protein tests for assessment on urine, CSF, plasma, and serum, enabling enhanced quantification of certain health conditions. With innovative assays including FLC, CDT, and BTP, the system supports the assessment and monitoring of cardiovascular risk, kidney diseases, neurological disorders, nutritional status, and other diseases.

  • Expand your testing capabilities with the broadest menu of protein tests on multiple sample types

  • Minimize hands-on time so laboratory staff can focus on high-value responsibilities

  • Streamline your lab workflows with highly intelligent software and IT connectivity

  • Deliver accurate and secure results with antigen excess security

  • Save time and reduce waste with continuous access and smart technology

  • Empower clinicians to improve patient outcomes

Features & Benefits

Expand your testing capabilities with the broadest menu of protein tests on multiple sample types

  • The industry’s largest nephelometric menu of plasma protein assays with more than 60 assay protocols available

  • Innovative assays including free light chains (FLC), carbohydrate-deficient transferrin (CDT), and beta-trace protein (BTP)

  • Supports a variety of disease states including cardiovascular risk assessment, kidney diseases, neurological disorders, nutritional assessment, iron and anemia assessment, and other diseases


Minimize hands-on time so laboratory staff can focus on high-value responsibilities

  • Flexible use of different sample types in random-access mode allows convenient operation

  • Onboard reagent and control storage provides 24/7 operation, long onboard stability, and minimized operator intervention

  • High sample-loading capacity allows load-and-go processing

  • Positive bar-code ID of primary sample tubes minimizes manual steps and avoids sample mismatch

  • Automatic dilutions and repeat measurement of out-of-range high or low samples are performed without user intervention


Save time and reduce waste with continuous access and smart technology

  • Flexible dilutions and automatic retesting can often be performed without re-accessing the primary sample

  • Fast average throughput of approximately 65 tests/hour depending on the assay mix. Nominal:100 tests/hour

  • Sophisticated sample dilutions enables you to add tests or retest samples quickly

  • Samples and reagents can be loaded and reloaded continuously without interrupting the assay run


BN ProSpec System

Small - 72 DPI-H_DX_BN-Prospec_wMonitor.

The BN ProSpec® is a dedicated, compact system that offers a consolidated menu of specialty and routine reagents for reliable plasma protein testing including cardiac risk assessment, kidney diseases, nutritional assessment and iron and anemia assessment as well as innovative markers such as monoclonal kappa and lambda free light chains, Cystatin C and Carbohydrate-Deficient Transferrin (CDT).

  • Ideal for low- to mid-volume plasma protein throughput

  • Comprehensive menu from one source: Over 64 assay protocols available for determination of various sample types

  • Optimal alignment of systems and reagents

  • Refrigerated onboard storage of controls and reagents

  • Assistance with clinical interpretation through our innovative range of assessment programs available for Protis® Data Management System.

Features & Benefits

The BN ProSpec® System uses our proven nephelometric technology for the determination of a large variety of assays which support the management of disease states such as iron and anemia assessment, gammopathies / immune system, kidney disease, and many others.  

The BN ProSpec System is a fully automated benchtop analyzer which combines efficient workflow with cost-effective determinations for plasma protein testing needs:

  • Patient-oriented sample processing for efficient workflow

  • Convenient handling due to onboard storage of reagents and controls

  • Highly reliable patient results with optimized system components

The BN ProSpec provides you with:

Increased workflow efficiency

  • Average effective throughput of 65 tests/hour

  • Onboard capacity for up to 1.5 hour walkaway convenience

  • 24-hour onboard refrigerated reagent storage to eliminate removal of controls and reagents

  • Enhanced onboard stability – generally up to 6 weeks for reagents and 1 week for controls

  • Barcode identification for primary sample tubes, standards, controls and reagents

  • Sample auto-dilution and configurable, automatic repeat measurements for fast results with less operator intervention

  • Secure interruption of assay runs for calibration and reloading – no loss of data

  • Specimen level-detection 

Confidence in results

  • Optimal alignment of reagents and system

  • High reliability with antigen-excess security

  • Proven nephelometric technology 

Comprehensive solutions

  • Broad menu available from one source: Over 64 assay protocols available for determination in various body fluids

  • Consolidation of specialty and routine parameters to support disease state management 

I

BN II System

Small - 72 DPI-H_DX_BNII_wMonitor_Barcod

The BN™ II System is an easy-to-use, reliable nephelometric analyzer that offers a broad range of protein assays. With assays available across multiple sample types, you can conveniently assess numerous disease states such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse—on just one system.

  • Designed for mid- to high-volume plasma protein throughput

  • Broad menu from one source; more than 60 assay protocols available for determination of various sample types

  • Up to 100 samples onboard

  • Antigen-excess security for confidence in results

  • Connectivity options to Aptio® Automation and FlexLab Automation solutions

  • Assistance with clinical interpretation through our innovative range of assessment programs available for Protis® Data Management System

Features & Benefits

As the first dedicated protein analyzer that can be connected to lab automation, the BN™ II System provides flexible options to meet the needs of the mid- to high-volume plasma protein lab. It uses nephelometric technology for protein determination and supports the clinical management of a variety of disease states, such as gammopathies, kidney diseases, neurology, and chronic alcohol abuse.

Increased workflow efficiency:

  • Fully automated assay processing: from reading of sample tube bar codes to reporting of results

  • Average throughput up to 130 tests per hour, and its high onboard capacity of up to 100 samples and 35 reagents provides a walkaway time of more than 2 hours

  • Wide measuring ranges enable fewer repeats

  • User-friendly software facilitates easy operation

  • Bidirectional host interface for convenient transfer of assay requests and results to the laboratory information system (LIS)

Flexible, efficient operation

  • Continuous loading and reloading of samples and/or reagents without interrupting the system’s current workload

  • Random-access processing eliminates sample batching

  • Accommodates standard sample tubes as well as micro cups for low-volume samples, such as samples from pediatric patients

Confident, consistent results

  • Confidence in results when analyzing samples with extremely high analytical concentrations

  • Optimized reaction conditions and assay-specific, automated pre-reaction protocols ensure valid results without operator intervention

  • Specimen level detection and positive barcode identification for samples, reagents, standards and controls to reduce human error

Innovative assay menu

  • Broad menu available from one source; over 60 assay protocols for management of various clinical indications

  • Routine and specialty assay consolidation

  • Innovative markers including monoclonal kappa and lambda free light chains (FLC), cystatin C, beta-trace protein (BTP), and carbohydrate-deficient transferrin (CDT)

Plasma Protein Assays

N Latex FLC kappa and N Latex FLC lambda Assays

flc_allboxes_reagents-16x9-06548425_8.jp

Free light chain (FLC) kappa and lambda Assays for use on Atellica® NEPH 630, BN™ II, and BN ProSpec® Systems are designed for more reliable management of patients with monoclonal gammopathies. Excellent/stable lot-to-lot reproducibility leads to improved diagnostic accuracy as well as the sensitive detection of changes in follow-up testing.

Add confidence to screening and monitoring of monoclonal gammopathies with N Latex FLC kappa and N Latex FLC lambda Assays:

  • High specificity based on monoclonal antibodies

  • Excellent lot-to-lot reproducibility

  • Pre-reaction protocol ensures high antigen-excess security

  • Flexible kit design: reagents, supplementary reagent, standard, and controls are available separately and can be freely combined

Features & Benefits

Consistent Results Help Refine Disease Management Strategies


Determination of free light chains (FLC) has been part of the officially recommended screening panel for multiple myeloma since 2009. Furthermore, FLC determination helps in monitoring therapy success. Reliable results are a prerequisite for consistently high sensitivity in screening and sensitive detection of changes in follow-up. Studies have shown the clinical concordance of the N Latex FLC Assays to competitive assays.
 

Excellent lot-to-lot consistency

  • Adds consistency to patient results and the follow-up of patients using different reagent lots.

  • Allows patient screening and monitoring of therapy, e.g., for myeloma patients.

  • Ensures improved patient management by early recognition of a potential relapse or resulting therapy adjustments – this may lead to an overall improved patient outcome.

Improved antigen-excess security

  • Feel more confident through detection of high-dose hook effects.

  • Improve cost-effectiveness due to fewer dilution steps.

Convenient packaging concept

  • Reduce costs with flexible, reagent-independent packaging. All components can be ordered separately, so you can ensure an adequate supply of standard and controls while eliminating waste.

  • Add confidence to screening and monitoring of monoclonal gammopathies with assays and systems from Siemens Healthineers.

N Latex BTP Assay

n-latex-btp-assay-16x9-06548426_8.jpg

The N Latex BTP assay for use on BN™ II and BN ProSpec® Systems is a fast and accurate screening method for detection of cerebrospinal fluid (CSF) and estimation of residual renal function (RRF). A fully automated, random-access assay, the N Latex BTP assay employs a latex-enhanced, polyclonal reagent that provides high sensitivity, specificity, and lot-to-lot reproducibility.

  • Two applications—one accurate, convenient, fully automated assay.

  • Fast and accurate detection of CSF leakage.

  • Easy and reliable determination of RRF in dialysis patients.

  • High specificity and sensitivity for accurate results.

  • Low incidence of false-positive results.

Features & Benefits

Fast and Accurate Detection of CSF Leakage
The new N Latex BTP Assay is the first fully-automated method to provide accurate, rapid, and cost-effective determination of CSF leakage with a simple, nephelometric lab test. Testing can be performed on minimal sample volumes of human serum, heparinized and EDTA-plasma, CSF, and nasal or ear secretions containing CSF. Results are comparable to the β2-transferrin immunofixation electrophoresis method, but faster, easier, and less expensive.

  • High specificity of 100% and sensitivity of 99% for accurate results.

  • Performance is not subject to CDT interference.

  • 12 minutes to result—time to result from sample collection to final result possible in 1 hour—less than half the time needed B2Trf, enabling faster surgical intervention.

  • Low incidence of false-positive results helps reduce costly imaging testing and possible loss of life due to misdiagnosis.


Simple and Precise Monitoring of RRF
Beta-trace protein (BTP) measurement with the N Latex BTP assay offers simpler sample retrieval and increased accuracy of RRF determination when compared to other methods. It is the first assay to accurately, reliably and simply estimate RRF status with one serum sample.

  • Only a single serum sample is needed for determination of BTP

  • Allows estimation of renal contribution to clearance - without inaccurate and cumbersome urine collection

  • Supports decisions regarding dialysis modality selection

  • Provides information clinicians need to adjust dialysis regimen as well as to anticipate and manage complications.

N Latex CDT Assay

n_latex_cdt_assay-16x9-06548427_8.jpg

The N Latex CDT assay for use on BN™ II and BN ProSpec® Systems provides a highly specific screening method for the detection of alcohol abuse. The CDT level increases and decreases with the amount of alcohol consumed; therefore, many different applications are possible, such as differential diagnosis of alcohol-induced versus nonalcohol-induced diseases, legal applications (e.g., for regranting of driver’s license), workplace testing, or forensic toxicology.

  • Fully automated immunoassay with no sample pretreatment required

  • Highly specific monoclonal antibody that directly detects CDT

  • Automatic calculation of %CDT by running CDT and transferrin assays simultaneously

  • Fast availability of results—within 20 minutes (total assay time)

  • Random-access capability

  • Reliable results—excellent recovery between labs, systems, and lots

Features & Benefits

Carbohydrate-deficient transferrin (CDT) is regarded as a very specific marker for identifying excessive alcohol consumption and monitoring abstinence during outpatient treatment.

Regular alcohol consumption of more than 50–80 g of ethanol per day for at least 2 weeks can result in a changed glycosylation pattern of transferrin, leading to a higher rate of isoforms lacking one or both entire carbohydrate chains. These isoforms (disialo- and asialotransferrin) are collectively named carbohydrate-deficient transferrin . After approximately 2–4 weeks of abstinence, CDT concentrations usually return to normal levels.

Compared to other markers, CDT offers superior sensitivity and specificity:

  • CDT is seemingly unaffected by liver diseases other than those induced by alcohol abuse (except biliary cirrhosis and chronic active hepatitis).

  • CDT is not influenced by common chronic diseases or medication.

  • CDT indicates the effectiveness of alcohol detoxification much earlier than gamma-glutamyl transferase or erythrocyte mean corpuscular volume, for example.


Based on an assumed cutoff of 2.5 %CDT, test results obtained with N Latex CDT on BN™ Systems exhibit a specificity of 97% and a sensitivity of 93% in comparison to the %CDT values determined with HPLC.

IgG Subclass 1–4 Immunoassays

igg_subclass-16x9-06548428_8.jpg

The determination of IgG subclass concentrations is indicated for diagnostic clarification in patients with increased susceptibility to infection, malfunctioning immune defense systems, and abnormally frequent and/or prolonged or severe infections that cannot be explained by standard clinical and laboratory data. Siemens Healthineers solution for IgG determination combines high precision with the trusted performance of the BN™ Systems for a comprehensive solution you can rely on.

  • Comprehensive solution for IgG determination from one source

  • Optimally aligned innovative assays and analyzers

  • Assay protocols with pre-reaction for antigen-excess security

  • The ability to measure all four subclasses provides insight into deficiencies that may be masked in a total IgG measurement or predominant IgG1.

Features & Benefits

Comprehensive solution for IgG determination from one source

  • Obtain reagents, supplementary reagents, analyzers, and service from one source

  • Reduce costs through a highly flexible and reagent-independent packaging concept: All components can be ordered separately, which helps to minimize waste and ensure supply of standard and controls.

Antigen-excess security for more accurate results

  • Feel more confident through detection of high-dose hook effects.

  • Improve cost-effectiveness due to fewer retests.

Precise results you can trust

  • Because IgG3 and IgG4 levels can dramatically rise in affected patients, a special cleaner solution is used to prevent carryover into the next sample measurement.

N Latex Cystatin C Assay

n_latex_cystatin_c_assay-16x9-06548446_8

Renal disease often progresses undetected, because kidney impairment does not cause pain. This is why chronic kidney disease is not diagnosed until patients show symptoms of an advanced stage of the disease. In the early stages of disease, laboratory testing is the most efficient and sensitive way to detect reduction in renal function.

Cystatin C shows increased sensitivity to renal dysfunction compared to serum creatinine, especially in the early stage of kidney disease characterized by a mild reduction in glomerular filtration rate.

The N Latex Cystatin C Assay:

  • Is suitable for both serum and plasma specimens

  • Has low imprecision (total CV <5%)

  • Runs on the Atellica® NEPH 630 System, BN™ II System, and BN ProSpec® System

Features & Benefits

Cystatin C is a nonglycated, low-molecular-weight (13 kDa) protein that is synthesized by all nucleated cells. It is produced at a constant rate regulated by a housekeeping gene. Cystatin C is freely filtered by the glomerulus, and there is no tubular secretion or any extrarenal elimination. In addition, cystatin C is not affected by muscle mass, diet, gender, or inflammation.

The relevance of determining cystatin C for diagnosis in CKD is included in the international KDIGO (Kidney Disease Improving Global Outcomes) guidelines.

No tubular secretion; sensitive in the creatinine-blind range

  • Higher sensitivity in early disease

Independent of age, sex, and muscle mass

  • Constant relationship between cystatin C and glomerular filtration rate (GFR) at 1 year of age and older

  • Single reference range: 0.62–1.11 mg/L in children and adults ranging in age from 1 to 78 years

  • Sensitive detection of declining GFR with aging

  • Reliable in patients with spina bifida, paralysis, amputations, etc.

High correlation to GFR reference methods; high correlation to GFR decline

  • High reliability and accuracy

Increased sensitivity compared to creatinine in liver disease patients or by creatinine intake. Cystatin C levels may be influenced by high-dose steroid therapy or thyroid dysfunction.