MAGLUMI 2000 Chemiluminescence Immunoassay (CLIA) System

Product Overview

The MAGLUMI 2000 is a fully automated, high-throughput chemiluminescence immunoassay system designed for mid to large-sized hospitals and clinical laboratories. Combining advanced labeling and separation technologies with a user-friendly interface, it delivers reliable performance, extensive test menu coverage, and cost-effective operation to meet high-volume testing demands.

Key Features

• Flash Chemiluminescence Labeling (ABEI): Non-enzyme small molecule label ensures high sensitivity and long-term stability, unaffected by storage condition changes.

• Superparamagnetic Microbead Separation: Enhances reaction speed, sensitivity, and accuracy by enlarging the reaction area and thoroughly mixing reagents in a liquid separation platform.

• Throughput: Up to 180 tests per hour.

• First Result: Ready in just 17 minutes.

• 24/7 Readiness: Always ready to use with refrigerated reagent area.

• Modes: Supports random, batch, and STAT operations.

• Sample Loading: Up to 144 sample tubes with continuous loading, STAT priority, barcode recognition, and LIS connectivity for automatic sample information reading.

• Reagent Management: Onboard capacity for 15 reagents, continuous loading, RFID tag for full traceability (storing all reagent information and built-in master curve), and 2-point calibration (calibration stability up to 4 weeks). Refrigerated reagent area with independent power supply.

• Pipettor: Titanium needle with TEFLON coating, crush-proof function, clot detection, liquid level detection, and internal/external washing to prevent carryover.

• Incubator: 16 incubator slots (96 tests simultaneously) with constant temperature control (36.8 ± 0.5°C).

• Automated Cuvette Loader: Capable of loading modules continuously, up to 120 reaction modules.

• Comprehensive Software: User-friendly interface, real-time status monitoring for each test, reagent and consumable status monitoring, intelligent alarm function, multilingual support (10 languages available, more upon request).

• Smart Maintenance: Step-by-step maintenance guide for daily, weekly, and monthly procedures to ensure performance reliability and reduce service calls.

• Quality Control: Westgard rules and Levey-Jennings chart for both internal and external quality control.

• Test Summary Function: Includes system test, calibration, QC, sample statistics, valid tests, and rerun tests for convenient search and review.

• Pre- and Post-Dilution: Available for high-concentration samples.

• Bidirectional LIS Connection: Via TCP/IP and COM.

Reagent Classification & Available Test Items

All reagents are ready-to-use, including calibrators. Available in 100 Tests/Kit and 50 Tests/Kit.

Thyroid

TSH (3rd Gen), T4, T3, FT4, FT3, Tg, TGA, Anti-TPO, TRAb, TMA, Rev T3, *T-Uptake

Hepatic Fibrosis

HA, PIIIP, N-P, C IV, Laminin, Cholylglycine

TORCH

Toxo IgG/IgM, Rubella IgG/IgM, CMV IgG/IgM, HSV-1/2 IgG/IgM, HSV-2 IgG, *HSV-2 IgM, *HSV-1 IgG/IgM

EBV

EBV EA IgG/IgA, EBV VCA IgG/IgM/IgA, EBV NA IgG/IgA

Inflammation Monitoring

hs-CRP, PCT, IL-6, SAA

Fertility

FSH, LH, HCG/β-HCG, PRL, Estradiol, Testosterone, free Testosterone, DHEA-S, Progesterone, free Estriol, 17-OH Progesterone, AMH, SHBG, Androstenedione, *PIGF, *sFlt-1

Hypertension

Direct Renin, Aldosterone, Angiotensin I, Angiotensin II, Cortisol, ACTH

Autoimmune

Anti-CCP, Anti-dsDNA IgG, ANA Screen, ENA Screen, Anti-Sm IgG, Anti-Rib-P IgG, Anti-Scl-70 IgG, Anti-Centromeres IgG, Anti-Jo-1 IgG, Anti-M2-3E IgG, Anti-Histones IgG, Anti-nRNP/Sm IgG, Anti-SS-B IgG, Anti-SS-A IgG, TGA, Anti-TPO, TRAb, TMA, ICA, IAA, GAD 65, Anti-IA2, *Anti-Cardiolipin IgG/IgM, *Anti-MPO

Immunoglobulin

IgM, IgA, IgE, IgG

Tumor Markers

AFP, CEA, Total PSA, f-PSA, CA 125, CA 15-3, CA 19-9, PAP, CA 50, CYFRA 21-1, CA 242, CA 72-4, NSE, S-100, SCCA, TPA-snibe, ProGRP, HE4, HER-2, PIVKA-II

Infectious Disease

HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc, Anti-HCV, Syphilis, Anti-HAV, HAV IgM, HIV Ab/Ag Combi, Chagas, HTLV I+II, H. pylori IgG/IgA/IgM, 2019-nCoV IgG/IgM, SARS-CoV-2 S-RBD IgG, SARS-CoV-2 Neutralizing Antibody, SARS-CoV-2 Ag, *Anti-HBc IgM

Drug Monitoring

Digoxin, CSA, FK506

Kidney Function

β2-MG, Albumin, *NGAL

Cardiac Markers

CK-MB, Troponin I, Myoglobin, hs-cTnI, H-FABP, NT-proBNP, BNP, D-Dimer, Lp-PLA2, *MPO

Metabolism

Pepsinogen I, Pepsinogen II, Gastrin-17, GH, IGF-1, IGFBP-3

Prenatal Screening

AFP, Free β-HCG, PAPP-A, free Estriol

Anemia

Vitamin B12, Ferritin, Folate, *RBC Folate, *EPO

Glyco Metabolism

C-Peptide, Insulin, GAD 65, Anti-IA2, ICA, IAA, Proinsulin

Bone Metabolism

Calcitonin, Osteocalcin, 25-OH Vitamin D, Intact PTH, *β-CrossLaps, *total P1NP

*Available soon

Technical Specifications

Why Choose MAGLUMI 2000?

• Designed for mid to large-sized hospitals with high-volume testing needs

• Extensive test menu covering all major clinical areas, with ongoing expansion

• Free quality control and calibrators help reduce cost per test

• Quality guaranteed by third-party QC and external quality assessment (EQA)

• Advanced ABEI labeling and magnetic microbead technology ensure stability and sensitivity

• High throughput with compact footprint and robust design

• User-friendly software with multilingual support and comprehensive monitoring features