MAGLUMI 4000 Plus Chemiluminescence Immunoassay (CLIA) System #

Product Overview

The MAGLUMI 4000 Plus is a fully automated, high-throughput chemiluminescence immunoassay system designed for laboratories and hospitals with demanding testing volumes. Combining advanced ABEI labeling and magnetic microbead separation technologies with modular expandability, it delivers exceptional stability, sensitivity, and operational efficiency to meet the most rigorous clinical testing requirements.

Key Features

• Flash Chemiluminescence Labeling (ABEI): Non-enzyme small molecule label ensures high sensitivity and long-term stability, unaffected by storage condition changes. The chemical reaction with NaOH and H₂O₂ completes in just 3 seconds.

• Magnetic Microbead Separation: Enhances reaction speed, sensitivity, and accuracy by enlarging the reaction area and thoroughly mixing reagents in a liquid separation platform, significantly reducing inter- and intra-assay discrepancies.

• Throughput: Up to 280 tests per hour.

• First Result: Ready in just 16 minutes.

• 24/7 Readiness: Always ready to use with refrigerated sample and reagent areas with independent power supply.

• Modes: Supports random access, batch, and emergency (STAT) operations.

• Modular Expandability: Sample capacity can be extended from 144 to 280 positions, adapting to growing laboratory needs. Compatible with total laboratory automation (TLA/LAS) systems, and supports modular integration with immunoassay, biochemistry, and ISE modules.

• Sample Loading: Up to 144 sample positions (expandable to 280), continuous loading, STAT priority, barcode recognition, and LIS connectivity for automatic sample information reading. Refrigerated sample area with independent power supply maintains sample integrity.

• Reagent Management: Onboard capacity for 25 reagents with continuous loading. RFID tags store all reagent information and built-in master curves. 10-point master curve with 2-point calibration (calibration stability up to 4 weeks). Refrigerated reagent area with independent power supply.

• Reagent Integral: Ready-to-use, no pretreatment required, with built-in calibrators.

• Pipettor: High-speed aspiration, titanium needle with crush-proof function, TEFLON coating to prevent carryover, clot detection, and liquid level detection.

• Patented Washer Design: Strong magnetic field for efficient separation with anti-overflow function.

• Automated Cuvette Loader: Continuous loading function for uninterrupted operation.

• Measuring Unit: High-sensitivity, low-noise photomultiplier tube (PMT) for precise detection.

• Incubator: Constant temperature control at 36.8 ± 0.5°C.

• Convenient Consumables Placement: Easy replacement of wash liquid, waste liquid, starters, and waste cuvettes.

• Comprehensive Software: User-friendly interface with color touch screen, real-time status monitoring for each test, reagent and consumable status monitoring, intelligent alarm function, and multilingual support.

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

• Quality Control: Westgard rules and Levey-Jennings charts 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: Automatic dilution with optional ratio for high-concentration samples.

• Reflex Testing: Editable ranges for reflex test functionality.

• 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 Generation), T4, T3, FT4, FT3, Tg (Thyroglobulin), TGA (Anti-Tg), TRAb, TMA, Anti-TPO, Rev T3, *T-Uptake

Hepatic Fibrosis

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

TORCH

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

EBV

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

Inflammation Monitoring

hs-CRP, PCT (Procalcitonin), IL-6, *SAA (Serum Amyloid A)

Fertility

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

Autoimmune

TGA (Anti-Tg), TRAb, TMA, Anti-TPO, ICA, IAA (Anti-Insulin), GAD 65, Anti-IA2, 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 (AMA-M2), Anti-Histones IgG, Anti-nRNP/Sm IgG, Anti-SS-B IgG, Anti-SS-A IgG, Anti-CCP, *Anti-Cardiolipin IgG, *Anti-Cardiolipin IgM, *Anti-MPO

Immunoglobulin

IgM, IgA, IgE, IgG

Kidney Function

β2-MG, Albumin, *NGAL

Tumor Markers

Ferritin, AFP, CEA, Total PSA, f-PSA, CA 125, CA 15-3, CA 19-9, HCG/β-HCG, Tg (Thyroglobulin), PAP, CA 50, CYFRA 21-1, CA 242, CA 72-4, NSE, S-100, SCCA, TPA-snibe, Pepsinogen I, Pepsinogen II, Gastrin-17, H. pylori IgG, H. pylori IgA, β2-MG, Calcitonin, Proinsulin, proGRP, HE4, HER-2, *PIVKA-II

Infectious Disease

HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc, Anti-HCV, Syphilis, Chagas, HTLV I+II, Anti-HAV, HAV IgM, HIV Ab/Ag Combi, H. pylori IgG, H. pylori IgA, H. pylori IgM, *Anti-HBc IgM

Drug Monitoring

CSA (Cyclosporine A), FK 506 (Tacrolimus), Digoxin

Cardiac Markers

CK-MB, Troponin I, Myoglobin, hs-cTnI, H-FABP, NT-proBNP, BNP, Aldosterone, Angiotensin I, Angiotensin II, Direct Renin, D-Dimer, Lp-PLA2, hs-CRP, *MPO

Prenatal Screening

AFP (Prenatal Screening), Free β-HCG, PAPP-A, HCG/β-HCG, free Estriol

Anemia

Vitamin B12, Ferritin, Folate (FA), *RBC Folate

Glyco Metabolism

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

Bone Metabolism

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

Others

Cortisol, GH (hGH), IGF-I, ACTH, IGFBP-3

*Available soon

Technical Specifications

Why Choose MAGLUMI 4000 Plus?

• Designed specifically for high-throughput laboratories and hospitals with demanding testing volumes

• Modular expandability to accommodate growing laboratory needs

• Broad 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

• Highest throughput in the MAGLUMI series with fastest time to first result (16 minutes)

• User-friendly software with real-time monitoring and comprehensive quality control features

• Compatible with total laboratory automation (TLA/LAS) systems for seamless integration