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SCREENING & DIAGNOSIS

Early Screening for Alzheimer's Disease

Class II Medical Device

Application Scenarios: Physical Examinations and Community Screenings

Early screening for Alzheimer's disease (AD) is a method to identify disease risk beforesymptom onset through a series of cognitive assessments, biomarker detections, andimaging examinations.

Alzheimer's disease is a chronic, degenerative disorder of the central nervous systemcharacterized by insidious onset and subtle cognitive or behavioral changes, often remainingundetected in its early stages

AD Biomarkers

Theoretical Basis for Blood-Based Detection

The typical histopathological changes in Alzheimer's disease (AD) include the depositionof β-amyloid (Aβ) plaques, neurofibrillary tangles caused by abnormal phosphorylationof 10 Tau protein, and the loss of neurons and synapses. Aβ1-42, Aβ1-40, and phosphorylatedTau (P-Tau) are currently widely recognized AD biomarkers both domestically andinternationally. Glial Fibrillary Acidic Protein (GFAP) not only tracks AD progression but alsodetects elevated GFAP levels in Aβ -positive individuals without cognitive impairment. Bymonitoring its aberrant expression during the preclinical phase of AD, timely diagnosis andintervention can be guided to effectively slow the progression of AD.

Blood-Based Detection VS Traditional Detection Methods

High-Sensitivity Blood Testing
Non-invasive, low cost

Convenient operation, suitable for widespread screening

✓

PET Molecular Imaging

Expensive, involves radiation risk, and has extremely low equipment availability

Lumbar Puncture for Cerebrospinal Fluid (CSF) Testing

Invasive procedure with infection risks

Product Details for Alzheimer's Disease (AD) Blood Test Kit

AB1-42/AB1-40/p-Tau-181/GFAP Combined Detection Kit (Flow Fluorescent Immunoassay Method)

Product Parameters

Parameter

Aβ1-42

Aβ1-40

p-Tau-181

GFAP

Sample Type

Plasma

Normal Reference Range

≥30pg/mL

≤400pg/mL

≤4pg/mL

≤23pg/mL

Linear Range

4.88-625pg/mL

9.77-1250pg/mL

1.25-160pg/mL

9.77-1250pg/mL

*The above ranges are for reference only. Due to differences in geography, race, gender, and age, each laboratory can establish its own reference ranges.

Product Specifications

Kit Model

Detection Indicators

Model A

Aβ1-40/Aβ1-42/p-Tau-181

Model B

Aβ1-40/Aβ1-42/GFAP

Model C

Aβ1-40/Aβ1-42/p-Tau-181/GFAP

Product Specifications

Physical Examination Department Geriatrics Department (or Department of Geriatric Medicine) Neurology Department Rehabilitation Department

Physical Examination Department Geriatrics Department (or Department of Geriatric Medicine) Neurology Department

Complete Indicators Accurate Results

A large-scale cross-sectional and follow-up clinical study involving over 1,000 cases was conducted. When the test results were compared with clinical gold standards such as Aβ-PET and DAT-PET imaging diagnoses, both sensitivity and specificity exceeded 80%.

User-Friendly Sampling Non-Invasive Testing

Non-invasive Testing Using Peripheral Blood: The test utilizes peripheral blood samples, which are easy to obtain and do not cause any trauma to the subjects. Small Sample Volume: Only a small amount of sample, less than 2 mL of serum, is required for the test.

Convenient Process Standardized Operations

Long-term Monitoring for Peace of Mind

Facilitates individuals and communities in conducting long-termmonitoringof Alzheimer's Disease (AD) symptom progression, enabling them to cherish and extendprecious moments while keeping the shadows of forgetfulness at bay.

0512-69885880 商务合作：13911441296/18625299566

wutl@carrierbiomed.com

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