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IVD-related Products and Services

In Vitro Diagnostics (IVD) are tests executed on samples acquired from the human body for the purpose of determining medical conditions and assisting diagnosis and therapy. IVD-related products are used to collect, prepare, or examine biopsy samples. The sensitivity, specificity, and performance consistency of products are therefore crucial for the precision and accuracy of the diagnosis. With refined production platforms for both recombinant antibodies and proteins, GeneTex is constantly expanding its catalog of IVD-related products and services for applications that include lateral flow assay (LFA), ELISA, and IHC-P.

 

GeneTex’s Advantages:

  • Superior Quality
  • Performance Consistency
  • Bulk Production for Gram-Scale Amounts
  • Production in the QMS Level IVD Laboratory
  • Comprehensive Antibody Pairs for IVD Product Development
  • International QMS Certifications:
ISO 9001:2015   ISO 13485:2016   ISO 14001:2015
ISO 9001:2015   ISO 13485:2016   ISO 14001:2015

 

 

 

Quality Recombinant Technique Platforms:

Recombinant Monoclonal Antibodies | Recombinant Proteins

IVD-related Products and Services:

Lateral Flow Assay (LFA) Development Service | Enzyme-Linked Immunosorbent Assay (ELISA) Development Service | Immunohistochemistry (IHC)-Validated Recombinant Antibodies

 

 

 

 

Lateral Flow Assay (LFA) Development Services
 

LFA Development Services:

 

LFA Development Products:

SARS-CoV-2 (COVID-19)

Capture:
SARS-CoV-2 (COVID-19) Nucleocapsid antibody
[HL455] (GTX635688)
 

Detection:
SARS-CoV-2 (COVID-19) Nucleocapsid antibody
[HL448] (GTX635686)
  

Samples:
1. SARS-CoV-2 (COVID-19) Nucleocapsid protein (GTX135592-pro) 
2. Lysis buffer

Influenza A Virus (FluA)

Capture:
Influenza A Virus Nucleoprotein antibody
[HL1078] (GTX636199)
   

Detection:
Influenza A Virus Nucleoprotein antibody
[HL1953] (GTX637790) 

Samples:
1. FluA Nucleoprotein (H1N1) (GTX135904-pro)
2. FluA Nucleoprotein (H3N2) (GTX136317-pro)
3. Lysis buffer

Influenza B Virus (FluB)

Capture:
Influenza B Virus Nucleoprotein antibody
[HL1069] (GTX636100)
 

Detection:
Influenza B Virus Nucleoprotein antibody
[HL1068] (GTX636099)
 

Samples:
1. Influenza B Virus Nucleoprotein (B/Victoria/02/1987) (GTX136277-pro)
2. Influenza B Virus Nucleoprotein (B/Sydney/3/2004) (GTX135867-pro) 
3. Lysis buffer

Respiratory Syncytial Virus (RSV)

Capture:
Respiratory Syncytial Virus Nucleoprotein
antibody [HL1248] (GTX636650)   

Detection:
Respiratory Syncytial Virus Nucleoprotein
antibody [HL1246] (GTX636648)  

Samples:
1. RSV type A Nucleoprotein (GTX136751-pro)
2. RSV type B Nucleoprotein (GTX136931-pro) 
3. Lysis buffer

3-in-1 Test for SARS-CoV-2, Flu A and Flu B

Capture:
S. SARS-CoV-2 (COVID-19) Nucleocapsid antibody
[HL455] (GTX635688)  
A. Influenza A virus Nucleoprotein antibody [HL1952] (GTX637789) 
B. Influenza B virus Nucleoprotein antibody [HL1073] (GTX636194)  

Detection:
S. SARS-CoV-2 (COVID-19) Nucleocapsid antibody
[HL448] (GTX635686)
  
A. Influenza A virus Nucleoprotein antibody [HL1078] (GTX636199)
   
B. Influenza B virus Nucleoprotein antibody [HL1068] (GTX636099)  

Samples (40 ng) :
1. Lysis buffer
2. Mixture of SARS-CoV-2 (GTX135592-pro), Flu A-H1N1 (GTX135904-pro), and Flu B Nucleoprotein (GTX135867-pro)

Human Papillomavirus type 16 E7

Capture:
Human Papillomavirus type 16 E7 antibody
[HL1647] (GTX637228) 

Detection:
Human Papillomavirus type 16 E7 antibody [HL1821] (GTX637546)   

Samples:
1. HPV16 E7 protein (GTX133411-pro) 
2. HPV18 E7 protein (GTX133412-pro)
3. Lysis buffer

   

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 Enzyme-Linked Immunosorbent Assay (ELISA) Development Services
 

ELISA Development Services:

 

Direct/Indirect ELISA

Virus subtype detection

Direct/Indirect ELISA

EC50 determination

Sandwich ELISA

Target protein detection and quantitation

Sandwich ELISA

Antibody pair screening

Competitive ELISA

Neutralizing antibody evaluation

     

ELISA Development Products:

SARS-CoV-2 Neutralizing Antibody ELISA Kit (Omicron BA.1 / BA.2 / BA.4 / BA.5)  (GTX537233)

SARS-CoV-2 Neutralizing Antibody ELISA Kit (Omicron BA.1 / BA.2 / BA.4 / BA.5)  (GTX537233)

SARS-CoV-2 Neutralizing Antibody ELISA Kit (Omicron BA.1 / BA.2 / BA.4 / BA.5)  (GTX537233)

 

 

  Comparable Abs Orthogonal Validation 

IL6

Capture:
IL6 antibody [GT1535] (GTX636571)

Detection:
IL6 antibody [HL2389] (GTX638598)  Comparable Abs Orthogonal Validation

Enterovirus D68

Capture:
Enterovirus D68 VP1 antibody [GT11610] (GTX633688)

Detection:
Enterovirus D68 VP1 antibody [HL1997] (GTX637898)  Orthogonal Validation

Tau (pThr181)

Capture:
Tau (phospho Thr181) antibody [HL2497] (GTX638855)   Orthogonal Validation

Detection:
Tau (phospho Thr181) antibody [HL2498] (GTX638856)  Orthogonal Validation

ANP

Capture:
ANP antibody [GT1068] (GTX634219)

Detection:
ANP antibody [HL2617] (GTX639071) 

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Immunohistochemistry (IHC)-Validated Recombinant Antibodies

HistoMAX – The Antibody Collection Specific for Human IHC-P

  • Dual validation for manual staining & main stream autostainer protocols – Dako/ Bond RX/ Ventana
  • Validation with >70 kinds of human normal tissues & relevant tumor tissues

Orthogonal Validation HistoMAX

Her2 / ErbB2 Ab [MSVA-340R] (GTX04428) HistoMAX

 

Breast Cancer

 

Normal Breast

 
   

Prostatic Acid Phosphatase Ab [MSVA-452M] (GTX04396) HistoMAX

 

Prostatic Adenocarcinoma

 

Normal Appendix Mucosa

 
   

PSynaptophysin Ab [MSVA-462R] (GTX04371) HistoMAX

 

Thyroid Medullary Carcinoma

 

Normal Cerebellum

 
   

Cytokeratin 14 Ab [MSVA-614R] (GTX04377) HistoMAX

 

Esophagus Squamous Cell Carcinoma

 

Normal Skin Squamous Epithelium

 
   

EpCAM antibody [MSVA-326R] (GTX04380) HistoMAX

 

Lung Adenocarcinoma

 

Normal Kidney

 
   

LI-Cadherin antibody [MSVA-517M] (GTX04447) Orthogonal Validation HistoMAX

 

Ileum Neuroendocrine Tumor

 

Normal Rectum Mucosa

 
   

 

 

Quality Recombinant Monoclonal Antibodies Validated for Human IHC-P

     

 

PD-L1 antibody [HL1041] (GTX635975)    Comparable Abs Orthogonal Validation 

PD-L1 (+)
Oral squamous cell carcinoma

 

PD-L1 (–)
Colorectal adenocarcinoma
PD-L1 (+)
Inflammatory cells

 

Placenta (mature)
PD-L1 (+)
Syncytiotrophoblast

 

Lung
PD-L1 (+)
Alveolar macrophages

 

Breast Cancer

53BP1 antibody [HL275]
(GTX635479)

Orthogonal Validation

B-Raf antibody [HL1606]
(GTX637085)

EpCAM antibody [HL1524] (GTX636998)

Orthogonal Validation

Estrogen Receptor alpha antibody [HL1082] (GTX636203)

Orthogonal Validation

Gasdermin D antibody [HL1430] (GTX636896)

Orthogonal Validation 

NRF2 antibody [HL1021]
(GTX635826)

Orthogonal Validation

SOD1 antibody [HL1652]
(GTX637250)

Vimentin antibody [HL1506] (GTX636980)

Orthogonal Validation

Colon Cancer

CYLD antibody [HL1260]
(GTX636662)

Mre11 antibody [HL1385]
(GTX636825)

RRM1 antibody [HL1230]
(GTX636578)

SCRIB antibody [HL1639]
(GTX637220)

Cervical Cancer

ATM (phospho Ser1981) antibody [HL1062] (GTX636086)

Orthogonal Validation

MMP1 antibody [HL1259]
(GTX636661)

   

Hepatocellular Cancer

ADFP antibody [HL2145]
(GTX638123)

HCK antibody [HL1673]
(GTX637272)

   

Lung Cancer

AKT1 antibody [HL1142]
(GTX636413)

Ataxin 3 antibody [HL1909] (GTX637658)

SQSTM1 / P62 antibody [HL1113] (GTX636328)

Orthogonal Validation

VPS35 antibody [HL1017]
(GTX635821)

Esophageal Cancer

PAX3 antibody [HL160]
(GTX635463)

Orthogonal Validation
     

Glioblastoma

SNAP91 antibody [HL1657] (GTX637255)

     

Ovarian Cancer

CD44 antibody [HL1650]
(GTX637231)

Orthogonal Validation

TSG101 antibody [4A10]
(GTX70255)

Orthogonal Validation
   

Pancreatic Cancer

RAS (G12D Mutant) antibody [HL10]
(GTX635362)

Orthogonal Validation

Thrombospondin 2 antibody [HL1140] (GTX636411)

Orthogonal Validation
   

Prostate Cancer

Androgen Receptor antibody [HL1049] (GTX636021)

Orthogonal Validation

Androgen Receptor
(ARv7 Splice Variant)
antibody [HL1240] (GTX636639)

Orthogonal Validation
   

 

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