Snibe MAGLUMI PAPP-A (CLIA)

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Product Details:

Features High sensitivity and specificity, ready-to-use reagents, compatible with Snibe MAGLUMI analyzers, rapid results, traceable to international standards
Frequency Not Applicable (Depends on analyzer protocol)
Function Determination of PAPP-A concentration in prenatal screening
Usage Type Diagnostic/Reagent Consumable
Shelf Life As indicated on manufacturer label (typically 12 months)
Accuracy Highly accurate, as validated during quality control
Display Type Not Applicable (Used with analyzer)
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Snibe MAGLUMI PAPP-A (CLIA) Price And Quantity

Snibe MAGLUMI PAPP-A (CLIA) Product Specifications

Portable No (Consumable for automated analyzers)
Condition New
Material Reagent Kit (For use with Automated Immunoassay Platform)
Dimension (L*W*H) Kit size as per manufacturer packaging
Color As per kit/packaging (typically colorless to pale)
Weight Kit weight as per manufacturer packaging
Usage Type Diagnostic/Reagent Consumable
Frequency Not Applicable (Depends on analyzer protocol)
Function Determination of PAPP-A concentration in prenatal screening
Features High sensitivity and specificity, ready-to-use reagents, compatible with Snibe MAGLUMI analyzers, rapid results, traceable to international standards
Measurement Range As specified by the kit insert (varies per lot and analyzer)
Equipment Type Clinical Laboratory Analyzer Reagent
Real-Time Operation Yes (Automated on compatible analyzers)
Use Quantitative determination of Pregnancy-Associated Plasma Protein A (PAPP-A) in human serum
Instruments Type Immunoassay Reagent for MAGLUMI platform
Storage Instructions Store at 2-8°C, protect from light
Display Type Not Applicable (Used with analyzer)
Accuracy Highly accurate, as validated during quality control
Power Source Not Applicable (Used with automated instrument)
Operating Type Automated
Wall Mounted No
Shelf Life As indicated on manufacturer label (typically 12 months)
Technology Chemiluminescent Immunoassay (CLIA)

Lot Stability Lot-specific stability information provided with each kit
Calibration Traceable to international reference standards; multi-point calibration
Testing Throughput Depends on analyzer and laboratory workflow
Sample Type Human serum
Package Contents Ready-to-use reagents, calibrators, and controls as per kit configuration
Intended Use For in vitro diagnostic use only (IVD)
Compatibility For use with Snibe MAGLUMI series analyzers (e.g., MAGLUMI 600, 800, 1000, 2000, 4000 and more)
Assay Time Typically within 30 minutes (varies per analyzer)
Analyte Pregnancy-Associated Plasma Protein A (PAPP-A)
Limit of Detection Ultra-sensitive as per kit insert specification
Regulatory Status For professional use only

Product Description

Brand	Snibe
Sample Type	Serum
Pack Size	100T
CAT No.	130211003M
Application	Bone Metabolism

The kit has been designed for the quantitative determination of Pregnancy-associated plasma protein A (PAPP-A) in human serum. The method can be used for samples over the range of 25-10000 mIU/L. The test has to be performed on the Fully-auto chemiluminescence immunoassay (CLIA) analyzer MAGLUMI (Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus, Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi 4000).

High Precision Prenatal Screening

The Snibe MAGLUMI PAPP-A (CLIA) kit offers clinicians and laboratories a precise and efficient tool for prenatal screening. By delivering quantitative results for PAPP-A in human serum, it plays a crucial role in early pregnancy assessments. The kit's high sensitivity and traceability provide confidence in the screening process, supporting timely and informed clinical decisions for expectant mothers.

Streamlined Workflow with Automated Platforms

Designed for seamless automation, this reagent kit works directly with Snibe MAGLUMI analyzers. It brings efficiency to routine laboratory operations, reducing manual errors and hands-on time. With ready-to-use components and rapid assay times, laboratories can optimize throughput and maintain reliable results during high-volume testing.

Reliable and Compliant Diagnostic Solution

Each Snibe MAGLUMI PAPP-A (CLIA) kit adheres to strict international standards, featuring lot-specific stability and comprehensive calibration. With a typical shelf life of 12 months and clear storage guidelines, the kit ensures diagnostics remain dependable and accurate for healthcare professionals throughout its use cycle.

FAQ's of Snibe MAGLUMI PAPP-A (CLIA):

Q: How does the Snibe MAGLUMI PAPP-A (CLIA) kit benefit clinical laboratories?

A: This kit streamlines prenatal screening by providing highly sensitive, quantitative measurement of PAPP-A in human serum, utilizing automated Snibe MAGLUMI analyzers. It minimizes manual intervention, delivers rapid results, and aligns with international calibration standards, supporting efficiency and accuracy in clinical workflows.

Q: What types of analyzers are compatible with the MAGLUMI PAPP-A (CLIA) reagent kit?

A: The reagent kit is designed specifically for use with Snibe MAGLUMI series analyzers, including models like MAGLUMI 600, 800, 1000, 2000, 4000, and additional compatible platforms, ensuring broad applicability within clinical laboratories that utilize these systems.

Q: When should the MAGLUMI PAPP-A assay be used during the diagnostic process?

A: It is typically utilized during first-trimester prenatal screening as part of early risk assessment for certain pregnancy-related conditions. The assay provides clinicians with quantitative PAPP-A levels, which are important for evaluating maternal and fetal health.

Q: Where should the kit be stored and how is it maintained?

A: The kit should be stored at 2-8C and protected from light to maintain reagent stability and performance. Each kit comes with lot-specific stability information, and proper storage according to manufacturer instructions preserves the integrity and accuracy of the assay.

Q: What is the process for running a PAPP-A test with this kit?

A: To perform the test, simply load the ready-to-use reagents, calibrators, and controls into a compatible Snibe MAGLUMI automated analyzer. The system then processes human serum samples and provides quantitative results-generally within 30 minutes, depending on the analyzer model and workflow.

Q: Can the MAGLUMI PAPP-A (CLIA) reagent kit be used for real-time diagnostics?

A: Yes, the reagent kit is intended for real-time operation on automated Snibe MAGLUMI analyzers, facilitating prompt and dependable results during routine diagnostics without manual intervention.

Q: What makes the MAGLUMI PAPP-A (CLIA) assay reliable for diagnostic use?

A: The kit incorporates multi-point calibration traceable to international reference standards, uses highly sensitive chemiluminescent immunoassay technology, and undergoes rigorous quality control to ensure accurate and reliable quantitative results for prenatal screening.

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