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SAPE, the universal reporter for molecular diagnostics

Luminex xMAP technology allows high-volume biomarker testing with features including fast detection speed, requiring only a small sample volume, detecting 3-500 targets within a single run, and detecting either nucleic acid or protein, etc.  

For twenty years, XMAP technology incorporates the technologies of fluorescent-labeled microsphere/beads, fluorescent emission detection, and signal processing. It becomes an ideal tool for researchers to conduct diagnostics assays for both clinical and research use. The following tables summarized companies utilizing xMAP for disease detection.

 

Table 1. Companies in China that currently develop xMAP products:

 

Company

Disease detection using xMAP  

Beijing Unionluck

Cerebrovascular disease.

Cardiovascular disease.

Ardent BioMed

Cerebrovascular and cardiovascular diseases,

Precision Medicine for cancer,

Infectious diseases,

Neurological System diseases, Rheumatoid immunological disease, General Health.

Shanghai Iven Biotech

Cancer diagnostics.

Tellgen Corporation

Cancer diagnostics,

HPV genotypes,

HB and TF via fecal occult blood, Reproductive health,

Liver Cirrhosis,

Autoimmune disease.

Bright-Innovation BioMed

Genetic disease,

personalized medicine.

 

The determining factor for high sensitivity is the quality and suitability of the reporter within the detection assay. Biotinylated labeled nucleic acids or proteins are Typically detected and amplified via streptavidin-phycoerythrin (SAPE) conjugate. However, the performance of SAPE conjugate varies due to the nature of proteins and their conjugation conditions. The quality of SAPE is determined by the high signal-to-noise ratio on the detection platform. Therefore, it is best to choose a supplier with a large production capacity (grams level) to ensure assay consistency. You may see here the performance of Flogen’s SAPE conjugate.

 

Through the discovery of genetic factors associated with disease or drug-metabolizing genes and understanding of clinically relevant single nucleotide polymorphism (SNPs) attributed to drug response, scientists can now detect the diseases occurrence, side effects, drug clearance with very high specificity and very high sensitivity compared to traditional biopsy. The following table summarizes the commercialized Luminex assay developed for disease testing, drug pharmacogenetics, and drug resistance.       

 

Table 2. Disease and its respective marker/indication:

 

Disease

Marker/indication 

Cardiovascular and Cerebrovascular

disease

Lp-PLA2 for future coronary heart disease and ischemic stroke  

Myeloperoxidase (MPO), H-FABP, NT-proBNP, MYO, CK-MB for coronary heart disease.

Cardiac troponin (cTn) for acute coronary heart disease.

Detect the anomaly of steroid metabolism. 

Precision Medicine for cancer

BRAF/KRAS/CYR2D6/EGFR/NRAS gene diagnostics,

Evaluate 50+ gene mutations for tumor-targeted drug selection, drug resistance monitoring, and prognostic assessment. 

Detect the genetic variation of targeted drugs for lung cancer, evaluate the sensitivity of targeted drugs for lung cancer, and evaluate the sensitivity and side effects of chemotherapy drugs.

Infectious diseases

Respiratory infection (COVID-19), Intestinal flora 16S RNA detection,

Metagenome Sequencing Detection.

Neurological System diseases

Pharmacogenetic Testing for the anti-dementia drug.  

Evaluate drug sensitivity, side effects, and dose changes for levetiracetam, Topiramate, Oxcarbazepine, and Sodium valproate drug.

Assisted epilepsy genetic diagnosis and treatment, pedigree screening, and pathogenic gene identifications.

Alzheimer's disease genetic testing and medication guidance.

Rheumatoid immunological disease

Immune cell function gene expression detection, Gout pathogenesis gene + individualized drug-gene detection,

HLA-B27 typing, Quantitative detection for Severe Immune Gene Deficiency (SCID), Diabetes susceptibility gene and drug-gene detection, Severe immune gene deficiency high-throughput genetic testing, Combined Comprehensive Immunodeficiency Test (CPIP).

Cancer diagnostics

1.        Quantitative detection of tumor markers in human serum in vitro: Concentration of CEA, NSE, SCCA, CYFRA 21-1, proGRP in human serum, CEA (carcinoembryonic antigen), NSE (neuron-specific enolase), SCCA (squamous cell carcinoma antigen), CYRFA21-1 (cytokeratin 19 fragments), ProGRP (precursor gastrin-releasing peptide).

2.        free/total prostate-specific antigen (F-PSA and T-PSA) concentrations.

3.        Concentrations of carbohydrate antigen 15-3 and human epididymal secretory protein 4 in serum.

4.        Various (AFP, CEA, NSE, CYFRA21-1, CA125, CA242, free-β-hCG, CA19-9, SCCA, T-PSA, F-PSA, CA15-3), liver cancer, various gastrointestinal tumors, Ovarian cancer, breast cancer, pancreatic cancer, choriocarcinoma, lung cancer, lung cancer, small cell lung cancer CEA (carcinoembryonic antigen), prostate cancer CYFRA21-1 (cytokeratin 19 fragments), NSE (neuron-specific enolation) enzyme), CA125 (carbohydrate antigen 125), SCCA (squamous cell carcinoma antigen).

5.        Early diagnosis and postoperative evaluation of colorectal cancer.

HPV genotypes

27 types of HPV genotyping.

HB and TF via fecal occult blood

Gastrointestinal bleeding disorders (hemoglobin (HB) and transferrin (TF) concentrations) to assist in the diagnosis of gastrointestinal bleeding disorders.

Reproductive health

Pre-pregnancy examination (Toxoplasma gondii, rubella virus, cytomegalovirus, herpes simplex virus type 1, herpes simplex virus type 2 IgG, IgM detection) female pre-pregnancy examination and parasite pathogen screening reagents in the first trimester, auxiliary risk analysis, to achieve prenatal and postnatal care.

Liver Cirrhosis

Quantitatively detects the concentrations of human serum laminin, type III procollagen N-terminal peptide, type IV collagen, and hyaluronic acid to assist in the diagnosis of liver fibrosis.

Autoimmune disease

Systemic lupus erythematosus (SLE), Sjögren's syndrome (SS), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), polymyositis (PM), primary biliary cholangitis (PBC) Detection indicators: ANAs: dsDNA, Nucleosome, Histone, Jo-1, Scl-70, PM/Scl, Ribosomal P, SS-B, SS-A 52, SS-A 60, RNP, Sm, AMA(M2), CENP B. PCNA; Plus: C1q).

Genetic disease

Fragile X Syndrome Genetic Testing, Spinal Muscular Atrophy Genetic Testing, Genetic testing for nonsyndromic hereditary deafness, Early diagnosis of nasopharyngeal cancer, Cervical cancer risk assessment in patients, Cervical cancer risk assessment in patients with high-risk HPV infection.

General well being

Analysis and measures of sun protection ability.

Hair classification and care.

Acne susceptibility classification and prevention.

Six analysis and Recommendations of Endocrine Balance Analysis and maintenance of anti-aging ability.

Analysis and measures of the radiation protection ability.

Obesity Risk and Weight Loss Recommendations.

Allergy analysis and prevention.

Complete set of beauty genetic testing.

Analysis and maintenance of anti-wrinkle ability.

Freckles and melanin risk and prevention.

Personalized medicine

Drug-induced deafness genetic testing,

Genetic testing of anticoagulant drugs for individualized use of cardiovascular and cerebrovascular diseases,

angina pectoris.

Genetic testing for personalized medicine in patients with hyperuricemia and gout.

Individualized folic acid genetic testing.