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Sekisui Diagnostics LLC
One Wall Street,
01803
Burlington, MA
USA
USA
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Our range of products
Product categories
- 03 Diagnostic tests
- 03.01 Clinical chemistry
- 03.01.04 Rapid tests in clinical chemistry
Rapid tests in clinical chemistry
- 03 Diagnostic tests
- 03.01 Clinical chemistry
- 03.01.05 Other equipment for clinical chemistry
Other equipment for clinical chemistry
- 03 Diagnostic tests
- 03.02 Immunochemistry testing, immunology testing
- 03.02.01 Immuno assay testing
Immuno assay testing
- 03 Diagnostic tests
- 03.02 Immunochemistry testing, immunology testing
- 03.02.02 Diagnostic rapid tests
Diagnostic rapid tests
- 03 Diagnostic tests
- 03.07 Other diagnostics
Other diagnostics
Our products
Product category: Diagnostic rapid tests
OSOM® Strep A Test
A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.
- Easy-to-read two color results
- 96% sensitivity; 98% specificity versus culture
- Includes 2 additional test sticks for external QC testing
- Results in 5 minutes
Product category: Diagnostic rapid tests
OSOM® Ultra Plus Flu A&B Test | CE MARKED
The OSOM® Ultra Plus Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection.
- Simple CLIA-waived procedure with pre-measured extraction buffer for swab samples
- Accurate, differentiated interpretation of results in 10 minutes to test and treat patients in one office visit
- Sample Type: Nasal swab and nasopharyngeal swab
- Product Availability: Market authorization obtained for EU only
Product category: Diagnostic rapid tests
OSOM® RSV/Adeno Test
The OSOM® RSV/Adeno test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) and/or Adenovirus antigens directly from nasal swabs or nasal suction fluid in patients suspected of having a viral respiratory infection. Throat swabs are also an acceptable sample type for the detection of Adenovirus antigens.
- Sensitivity versus PCR > 90% (RSV); 85% (Adenovirus)
- Differentiates between RSV and Adenovirus
- Easy-to-read 3 distinct lines
- Less than 1 minute hands-on time; results in 10 minutes or less.
Product category: Diagnostic rapid tests
OSOM® Trichomonas Test
- The only CLIA-waived rapid test for the detection of Trichomoniasis
- 95% agreement with culture and wet mount combined
- Detects the antigen; does not require live organism
- Results in 10 minutes or less
- Objective easy-to-read two-color results
Product category: Diagnostic rapid tests
OSOM® BVBLUE® Test
Detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus.
- 92.8% sensitive, 98% specific versus Gram Stain
- 1 minute hands-on-time; 10 minute read time
- Instant color change provides clear easy-to-read results.
Product category: Diagnostic rapid tests
OSOM® Mono Test
For the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood.
- Results in 5 minutes
- > 99% sensitivity ; 96% specificity
- No age limitation
- 2 Additional test sticks for external QC
- Easy-to-read two color results
Product category: Diagnostic rapid tests
FastPack® IP Automated System
The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescent technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button.
Vitamin D, PSA, Free PSA, Testosterone, TSH, Free T4 and hCG
Vitamin D, PSA, Free PSA, Testosterone, TSH, Free T4 and hCG
Product category: Other diagnostics
Enzymes and Critical Raw Materials
For more than 40 years, SEKISUI Diagnostics has been providing high-quality, cost-effective enzymes and biochemicals to diagnostic reagent & biosensor manufacturers and research labs around the world.
- Clinical Chemistry
- Point of Care
- Biosensors
- Molecular Diagnostics
- Immunoassays
Product category: Other diagnostics
SEKISUI Veredus: VereRT™ ZeroPrep™ COVID-19 PCR Kit
Reverse Transcription Polymerase Chain Reaction (RT-PCR)-based In Vitro Diagnostic (IVD) test intended for the qualitative detection of nucleic acid belonging to SARS-CoV-2. This test is suitable for use directly from either (1) Viral Transport Media (VTM) / Universal Transport Media (UTM) containing nasopharyngeal swab specimen; OR (2) Human saliva specimen.
Both specimen types do not require viral RNA extraction prior to testing.
Compatibility
• VTM* / UTM* containing nasopharyngeal swab specimen
• Human saliva specimen collected using ZeroPrep™ Saliva Collection Kit
(* validated with 5 different brands of VTM / UTM)
Gene Targets
• Dual N1 and N2 gene targets (FAM)
• Human RPP30 as Internal Control (HEX)
Time-to-Result
• Approximately 90 mins
Sensitivity
• 10 viral RNA copies per test (4 viral RNA copies per uL Saliva)
Specificity
• No cross-reactivity with human genome / other coronaviruses / respiratory viruses
Territories
Europe, Middle East and Africa
Both specimen types do not require viral RNA extraction prior to testing.
Compatibility
• VTM* / UTM* containing nasopharyngeal swab specimen
• Human saliva specimen collected using ZeroPrep™ Saliva Collection Kit
(* validated with 5 different brands of VTM / UTM)
Gene Targets
• Dual N1 and N2 gene targets (FAM)
• Human RPP30 as Internal Control (HEX)
Time-to-Result
• Approximately 90 mins
Sensitivity
• 10 viral RNA copies per test (4 viral RNA copies per uL Saliva)
Specificity
• No cross-reactivity with human genome / other coronaviruses / respiratory viruses
Territories
Europe, Middle East and Africa
About us
Company portrait
Headquartered in Burlington, MA, for over 35 years SEKISUI Diagnostics has been committed to helping improve the lives of patients by providing innovative medical diagnostics to physicians and laboratories. We have a history of innovation which includes, the first homogeneous test for LDL and the first plastic vacuum blood collection tube. We continue to invest in the areas of diabetes, infectious disease, coagulation, diagnostic enzymes and automated systems, and have a leading position as a provider of rapid tests in the US and high throughput coagulation systems in Japan.
Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan and in China, making us a worldwide company with R&D and Manufacturing facilities on three continents.
We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include:
· Clinical chemistry reagents
· Coagulation systems and reagents
· Point-of-care molecular, rapid tests and immunoassay system
· Enzymes and specialty biochemicals
Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan and in China, making us a worldwide company with R&D and Manufacturing facilities on three continents.
We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include:
· Clinical chemistry reagents
· Coagulation systems and reagents
· Point-of-care molecular, rapid tests and immunoassay system
· Enzymes and specialty biochemicals
