Gold Standard Diagnostics develops and manufactures bioanalytical test kits, reagents, culture media and analyzers for laboratory diagnostics.
Gold Standard Diagnostics
Horsham, PA (US) · Frankfurt (DE) · Kassel (DE) · Madrid (ES) · Budapest (HU) · Trieste (IT)New on Amplifa
About Gold Standard Diagnostics
Gold Standard Diagnostics (GSD) is a global network of companies with decades of experience in the development and manufacture of test kits, reagents and instruments for bioanalytical diagnostics. The portfolio comprises around 2.500 diagnostic assays in 16 product lines – including ELISA, PCR and LFD test kits for allergens, mycotoxins, pathogens, GMOs, veterinary drug residues, veterinary and clinical applications as well as environmental analysis. In-house R&D and manufacturing teams also develop monoclonal and polyclonal antibodies, magnetic particles and magnetic beads as well as certified reference materials. BACGro brand culture media are produced in an ISO-9001:2015- and ISO-13485:2016-certified facility in Horsham, Pennsylvania (USA); in addition, environmental sampling devices (EZ Reach, PUR-Blue, VeriSwab) are manufactured from medical-grade polyurethane and polypropylene. Customers from 62 countries in the food, feed, environmental, biopharma, animal health and clinical diagnostics sectors are served from locations including Frankfurt, Kassel, Madrid, Budapest and Trieste.
- Site
- Horsham, PA (US)
- Processes
- Development and manufacture of diagnostic test kits (ELISA, PCR, LFD), Development and manufacture of magnetic particles, magnetic beads and purification kits, Instrument support and training/webinars, Antibody and antigen purification, Monoclonal and polyclonal antibody production, Custom Manufacturing & Packaging (Culture Media), Certified reference materials, Magnetic separators and custom magnetic particles
- Materials
- Polyurethane (PUR, medical-grade), Polypropylene, Dacron (swab tip), Polyurethane (medical-grade), Dacron
- Certificates
- ISO 9001:2015, ISO 13485:2016
- Industries
- Food, Feed, Environment, Biopharma, Animal health/Veterinary diagnostics, Clinical diagnostics
- 01
R&D (assay development)
- 02
Antibody production and purification
- 03
Manufacture of reagents, culture media and sampling devices
- 04
Instrument manufacturing (ELISA analyzers)
- 05
Quality control
- 06
Sales and customer service
Materials & Processes
Polyurethane (medical-grade)
Medical-grade polyurethane foam for EZ Reach Sponge Sampler and PUR-Blue Swab Sampler; tear- and lint-free during sampling.
Polypropylene
Used for the screw-cap sample tubes of the VeriSwab sampler.
Dacron
Swab tip material of the VeriSwab sampler with a visible blue shaft, terminal sterilization by gamma irradiation.
Locations
Horsham, PA
USCulture media manufacturing (BACGro), ABRAXIS sales
- Materials
- Culture media
Frankfurt
DEClinical Solutions
Kassel
DEAllergies and Food Sensitivity
Madrid
ESVeterinary Diagnostics
Budapest
HUCustomer Service Europe & APAC
Trieste
ITOrder processing (Italy)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and manufacture of diagnostic test kits (ELISA, PCR, LFD)Testing | – | – | – | – | – |
| Testing | – | – | – | – | – |
| Development and manufacture of magnetic particles, magnetic beads and purification kitsTesting | – | – | – | – | – |
| Testing | – | – | – | – | – |
| Testing | – | – | – | – | Polyurethane, Polypropylene, Dacron |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| ELISA analyzer | Gold Standard Diagnostics ThunderBolt® ELISA Analyzer | – | – | – | – |
| ELISA+CLIA analyzer | Gold Standard Diagnostics ThunderBolt® ELISA + CLIA Analyzer | – | – | – | – |
| ELISA analyzer | Gold Standard Diagnostics The BOLT™ ELISA Analyzer | – | – | – | – |
| ELISA+CLIA analyzer | Gold Standard Diagnostics The BOLT™ ELISA + CLIA Analyzer | – | – | – | – |
| Magnetic separator | – | – | – | – | – |
Additional services
Quality & Certifications
The culture media facility in Horsham is certified to ISO 9001:2015 and ISO 13485:2016; pathogen test kits are AOAC- and AFNOR-certified. In-house quality and R&D teams support customers with evaluation, validation and accreditation of immunoassays.
| Evidence | Horsham, PA |
|---|---|
| ISO 9001:2015 | |
| ISO 13485:2016 |
History
Establishment of a global network of companies with decades of experience in the development and manufacture of test kits, reagents and instruments; today 14 manufacturing and R&D locations and customers in 62 countries.