SA Scientific
SA Scientific, Ltd. has been serving clinical laboratories worldwide since 1984, designing, developing, and manufacturing a wide range of rapid diagnostic tests for fertility, infectious diseases, food pathogens, veterinary, and environmental testing. The company is committed to providing innovative, reliable, and cost-effective diagnostic testing devices, with a focus on research and development, quality, and global service. It operates in accordance with Good Manufacturing Practices and holds certifications including ISO 13485:2016, ISO 9001-2008, CE Mark, and others. The company aims to support health professionals with accurate and rapid pathogen detection methods and continues to expand its product portfolio and technological capabilities.
Industries
Nr. of Employees
medium (51-250)
SA Scientific
San Antonio, Texas, United States, North America
Products
Pregnancy (hCG) Serum/Urine rapid test
Membrane-based rapid immunoassay for hCG detection in serum or urine with documented analytical sensitivity and rapid time-to-result.
Pregnancy (hCG) One-Step / Dipstick
Urine lateral flow dipstick for hCG detection designed for rapid point-of-care use with CLIA categorization indicated in product documentation.
Pregnancy (hCG) Higher-sensitivity Serum/Urine test
Lateral flow test variant with improved analytical sensitivity for serum and urine matrices and documented performance characteristics.
Rotavirus rapid test
Membrane-based rapid assay for detection of rotavirus in stool with documented sensitivity and specificity and short time-to-result.
Adenovirus rapid test
Rapid lateral flow assay for adenovirus detection across multiple specimen types with documented sensitivity and specificity.
Reader for fluorescent and visual lateral flow tests
Instrument for automated readout of fluorescent and visual lateral flow assays to provide objective interpretation and improved sensitivity.
Pregnancy (hCG) Serum/Urine rapid test
Membrane-based rapid immunoassay for hCG detection in serum or urine with documented analytical sensitivity and rapid time-to-result.
Pregnancy (hCG) One-Step / Dipstick
Urine lateral flow dipstick for hCG detection designed for rapid point-of-care use with CLIA categorization indicated in product documentation.
Pregnancy (hCG) Higher-sensitivity Serum/Urine test
Lateral flow test variant with improved analytical sensitivity for serum and urine matrices and documented performance characteristics.
Rotavirus rapid test
Membrane-based rapid assay for detection of rotavirus in stool with documented sensitivity and specificity and short time-to-result.
Adenovirus rapid test
Rapid lateral flow assay for adenovirus detection across multiple specimen types with documented sensitivity and specificity.
Reader for fluorescent and visual lateral flow tests
Instrument for automated readout of fluorescent and visual lateral flow assays to provide objective interpretation and improved sensitivity.
Services
Contract development and manufacturing (OEM)
Technical collaboration to develop and manufacture rapid diagnostic test kits for clinical, veterinary and food-safety applications; OEM production and international distribution.
Technical development and regulatory support
Assay development support including analytical performance specification, CLIA categorization, preparation of package inserts/CLSI guides and other regulatory documentation.
Supply of control materials and validation kits
Manufacture and supply of positive/negative control vials and control sets for kit verification and ongoing quality control.
Contract development and manufacturing (OEM)
Technical collaboration to develop and manufacture rapid diagnostic test kits for clinical, veterinary and food-safety applications; OEM production and international distribution.
Technical development and regulatory support
Assay development support including analytical performance specification, CLIA categorization, preparation of package inserts/CLSI guides and other regulatory documentation.
Supply of control materials and validation kits
Manufacture and supply of positive/negative control vials and control sets for kit verification and ongoing quality control.
Expertise Areas
- Lateral flow assay development
- Point-of-care diagnostic development
- Isothermal nucleic acid amplification assays
- Quality management systems and GMP manufacturing
Key Technologies
- Colloidal-gold lateral flow assays
- Fluorescent lateral flow detection
- Isothermal nucleic acid amplification
- Membrane-based rapid immunoassays