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 9001:2015

ISO 13485:2016

ISO 13485:2016

ISO 14001:2015

ISO 14001:2015

     

Quality Recombinant Technique Platforms

 

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

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SARS-CoV-2 (COVID-19)

Capture:

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

 

Detection:

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

 

Samples:
1. SARS-CoV-2 (COVID-19) Nucleocapsid protein

 

2. Lysis buffer

 

Influenza A Virus (FluA)

Capture:
Influenza A Virus Nucleoprotein antibody
[HL1078]

 

 

Detection:
Influenza A Virus Nucleoprotein antibody
[HL1953]

 

Samples:
1. FluA Nucleoprotein (H1N1)

2. FluA Nucleoprotein (H3N2)

3. Lysis buffer

 

Influenza B Virus (FluB)

Capture:
Influenza B Virus Nucleoprotein antibody
[HL1069]

 

Detection:
Influenza B Virus Nucleoprotein antibody
[HL1068]

 

Samples:
1. Influenza B Virus Nucleoprotein (B/Victoria/02/1987)

2. Influenza B Virus Nucleoprotein (B/Sydney/3/2004)

3. Lysis buffer

 

     

Respiratory Syncytial Virus (RSV)

Capture:

Respiratory Syncytial Virus Nucleoprotein
antibody [HL1248]

 

 

Detection:

Respiratory Syncytial Virus Nucleoprotein
antibody [HL1246]

 

Samples:
1. RSV type A Nucleoprotein

2. RSV type B Nucleoprotein

3. Lysis buffer

 

3-in-1 Test for SARS-CoV-2,

Flu A and Flu B

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

A. Influenza A virus Nucleoprotein antibody [HL1952]

 

B. Influenza B virus Nucleoprotein antibody [HL1073]

 

 

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

  

A. Influenza A virus Nucleoprotein antibody [HL1078] 

   

B. Influenza B virus Nucleoprotein antibody [HL1068]

 

 

Samples (40 ng):
1. Lysis buffer

2. Mixture of SARS-CoV-2

and Flu B Nucleoprotein

 

Human Papillomavirus type 16 E7

Capture:
Human Papillomavirus type 16 E7 antibody
[HL1647]

 

Detection:
Human Papillomavirus type 16 E7 antibody [HL1821]

  

 

Samples:
1. HPV16 E7 protein

2. HPV18 E7 protein

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)

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

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

     

 

Comparable Abs

IL6

Capture:

IL6 antibody [GT1535]

 

Detection:

IL6 antibody [HL2389]

 

 

Enterovirus D68

Capture:
Enterovirus D68 VP1 antibody [GT11610]

 

Detection:
Enterovirus D68 VP1 antibody [HL1997]

 

 

Tau (pThr181)

Capture:
Tau (phospho Thr181) antibody [HL2497]

  Orthogonal Validation

 

Detection:
Tau (phospho Thr181) antibody [HL2498]

 Orthogonal Validation

 

     

ANP

Capture:

ANP antibody [GT1068]

 

Detection:

ANP antibody [HL2617]

 

   
     

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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

    Recombinant 

 

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

Breast Cancer

Normal Breast

   

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

Prostatic Adenocarcinoma

Normal Appendix Mucosa

   

PSynaptophysin Ab [MSVA-462R] (GTX04371)

Thyroid Medullary Carcinoma

Normal Cerebellum

   

 

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

Esophagus Squamous Cell Carcinoma

Normal Skin Squamous Epithelium

   

 

EpCAM antibody [MSVA-326R] (GTX04380)

Lung Adenocarcinoma

Normal Kidney

   

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

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]

B-Raf antibody [HL1606]

EpCAM antibody [HL1524]

Estrogen Receptor alpha antibody [HL1082]

       

Gasdermin D antibody [HL1430]

NRF2 antibody [HL1021]

SOD1 antibody [HL1652]

Vimentin antibody [HL1506]

       

Colon Cancer

CYLD antibody [HL1260]

Mre11 antibody [HL1385]

RRM1 antibody [HL1230]

SCRIB antibody [HL1639]

       

Cervical Cancer

ATM (phospho Ser1981) antibody [HL1062]

MMP1 antibody [HL1259]

   

Hepatocellular Cancer

ADFP antibody [HL2145]

HCK antibody [HL1673]

   

Lung Cancer

AKT1 antibody [HL1142]

Ataxin 3 antibody [HL1909]

SQSTM1 / P62 antibody [HL1113]

VPS35 antibody [HL1017]

       

Esophageal Cancer

PAX3 antibody [HL160]

 

Glioblastoma

SNAP91 antibody [HL1657]

 

Ovarian Cancer

CD44 antibody [HL1650]

TSG101 antibody [4A10]

   

Pancreatic Cancer

RAS (G12D Mutant) antibody [HL10]

Thrombospondin 2 antibody [HL1140]

   

Prostate Cancer

Androgen Receptor antibody [HL1049]

Androgen Receptor
(ARv7 Splice Variant)
antibody [HL1240]

   

 

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