Sekisui Diagnostics LLC of Burlington, MA at MEDICA 2020 in Düsseldorf -- COMPAMED Trade Fair
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Sekisui Diagnostics LLC

One Wall Street, 01803 Burlington, MA
USA
Telephone +1 800 33211042
Fax +1 800 7626311
info@sekisui-dx.com

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Contact

Sales and Marketing

Phone
+44 1622 607800

Email
info@sekisui-dx.com

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

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

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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

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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.

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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

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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.

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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

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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

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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

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Product category: Other equipment for clinical chemistry

Clinical Chemistry Reagents

SEKISUI Diagnostics is a recognised leader in the development, manufacture, and supply of innovative Clinical Chemistry Reagents, with over 1.7 billion tests performed each year using our products. 

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Product category: Other diagnostics

Products for Pre-Analytic Systems

Auxilliary materials used in serum tubes for blood collection tube manufacturers worldwide

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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

 

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About us

Company details

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

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Company information as a PDF file