IVD-related Products and Services

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

GeneTex’s Advantages:

Superior Quality
Performance Consistency
Bulk Production for Gram-Scale Amount
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

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)

IL6

Capture:
IL6 antibody [GT1535] (GTX636571)

Detection:
IL6 antibody [HL2389] (GTX638598)

Enterovirus D68

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

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

Tau (pThr181)

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

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

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