Lenzilumab ELISA Kit

Catalog No.

KDC06701

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CSF2 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Lenzilumab in the sample competitively binds to the pre-coated protein with biotin-labeled Lenzilumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Lenzilumab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

Used for the quantitative determination of Lenzilumab concentration in serum and plasma.

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

234.38 - 15,000 ng/mL

Sensitivity

118.12 ng/mL

Precision

Intra-Assay Precision (Precision within an assay): <20%

Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.

Inter-Assay Precision (Precision between assays): <20%

Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

	Intra-Assay Precision			Inter-Assay Precision
Sample	1	2	3	1	2	3
n	16	16	16	24	24	24
Mean (ng/mL)	7024.1	1780.5	485.3	7028.7	2140.8	563.4
Standard deviation	446.5	72.5	65.1	430.6	119.2	78.2
CV (%)	6.4	4.1	13.4	6.1	5.6	13.9

 

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.

Alternative Names

KB-003, CAS: 1229575-09-0

Background

Lenzilumab is a novel Humaneered ® anti-human GM-CSF monoclonal antibody that directly binds GM-CSF and prevents signaling through its receptor. The LIVE-AIR Phase 3 randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of lenzilumab to assess the potential for lenzilumab to improve the likelihood of ventilator-free survival (referred to herein as survival without ventilation, SWOV), beyond standard supportive care, in hospitalized subjects with severe COVID-19.

A Glimpse for the subsistence from pandemic SARS-CoV-2 infection., PMID:39603070

Reduction of therapeutic antibody self-association using yeast-display selections and machine learning., PMID:36433737

[Current and future therapeutic options for COVID-19]., PMID:36036702

C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 'LIVE-AIR' trial., PMID:35793833

Clinical and Economic Benefits of Lenzilumab Plus Standard of Care Compared with Standard of Care Alone for the Treatment of Hospitalized Patients with Coronavirus Disease 19 (COVID-19) from the Perspective of National Health Service England., PMID:35444434

In inpatients with COVID-19 who need supplemental oxygen, lenzilumab increased ventilation-free survival., PMID:35377717

Specific Interleukin-1 Inhibitors, Specific Interleukin-6 Inhibitors, and GM-CSF Blockades for COVID-19 (at the Edge of Sepsis): A Systematic Review., PMID:35126138

Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with COVID-19 in the United States from the hospital perspective., PMID:35037816

Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial., PMID:34863332

Clinical Characteristics and Outcomes of Patients Hospitalized for COVID-19 Pneumonia Who Developed Bradycardia., PMID:34215897

Increasing recognition and emerging therapies argue for dedicated clinical trials in chronic myelomonocytic leukemia., PMID:34175902

LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED COVID-19 SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL., PMID:33972949

Risk-Adapted, Individualized Treatment Strategies of Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)., PMID:33807279

In Reply - Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019., PMID:33673930

Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019., PMID:33673929

GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study., PMID:33153629

Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies., PMID:32719685

Pharmaco-Immunomodulatory Therapy in COVID-19., PMID:32696108

First Clinical Use of Lenzilumab to Neutralize GM-CSF in Patients with Severe COVID-19 Pneumonia., PMID:32587983

Treatment Considerations for COVID-19: A Critical Review of the Evidence (or Lack Thereof)., PMID:32561148

Case report: use of lenzilumab and tocilizumab for the treatment of coronavirus disease 2019., PMID:32546029

Phase 1 study of lenzilumab, a recombinant anti-human GM-CSF antibody, for chronic myelomonocytic leukemia., PMID:32294158

GM-CSF inhibition reduces cytokine release syndrome and neuroinflammation but enhances CAR-T cell function in xenografts., PMID:30463995

Document Download

Lenzilumab ELISA Kit.pdf