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OSOM® Trichomonas Test SEKISUI DIAGNOSTICS
The only CLIA-waived rapid test for Trichomonas. Detects the antigen so no hurrying to the microscope to see motile organisms. More sensitive than wet mount. Results in 10 minutes or less.


OSOM® Trichomonas Test

The OSOM® Trichomonas Test is intended for the qualitative detection of Trichomonas vaginalis (“Trichomonas”) antigens from vaginal swabs or from the saline solution prepared when making wet mounts from vaginal swabs.

Features and Benefits
  • 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
  • Controls included in the kit


Description Catalog# Configuration Storage Shelf Life
OSOM® Trichomonas Test 181 25-Test Room Temperature 16 months
OSOM® Trichomonas Control Kit 182 10 Positive Swabs Room Temperature 19 months
OSOM® Vaginitis Transport Set (for use with OSOM® Trichomonas and OSOM® BVBlue) 185 Room Temperature


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® Ultra Strep A SEKISUI DIAGNOSTICS
Clear, accurate results in minutes can help everyone feel better before the office visit is over.VERY ACCURATE – 96% sensitivity; 98% specificity.FAST- Results in 5 minutes.EASY-TO-READ – Two-color results.CONVENIENT – Compact packaging. Available in 25 or 50 tests. Kit Includes positive and negative controls. 50 Test Kit includes 2 additional test sticks to run QC.


OSOM® Ultra Strep A Test

A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.

Features and Benefits
  • Easy-to-read two-color results
  • Not statistically different than single swab culture (refer to instructions for use)
  • Results in 5 minutes
  • CPT Code: 87880QW


Description Catalog# Configuration Storage Shelf Life
OSOM® Ultra Strep A Test 149 50 Test (plus 2 extra for external QC) Room Temperature 15 months
OSOM® Ultra Strep A Test 147 25 Tests Room Temperature 15 months


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® Mono Test SEKISUI DIAGNOSTICS
Detects heterophile antibodies to EBV (monocucleosis) in serum, plasma, or whole blood. Easy-to-read two color results. 100% sensitivity, 99% specificity. No age restriction. Result in five minutes or less. Room temperature storage.


OSOM® Mono Test

For the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood.

Features and Benefits
  • Results in 5 minutes
  • > 99% Sensitivity; 96% specificity
  • No age limitation
  • Easy-to-read two-color results
  • Serum, plasma or whole blood
  • CPT Code: Whole blood 86308QW / Serum or plasma 86308


Description Catalog# Configuration Storage Shelf Life
OSOM® Mono Test 145 25 Tests (plus 2 extra for external QC) Room Temperature 12 months


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® BVBLUE® Test SEKISUI DIAGNOSTICS
The OSOM BVBLUE Test detects elevated vaginal fluid sialidase, an enzyme produced by pathogens associated with Bacterial Vaginosis including Gardnerella, Bacteroides, Prevotella and Mobilincus. CLIA-waived objective results in 10 minutes.


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.

Features and Benefits
  • CLIA-Waived
  • 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.
  • CPT Code: 87905QW


Description Catalog# Configuration Storage Shelf Life
OSOM® BVBLUE® Test 183 25-Test (plus 2 extra for external QC) Refrigerated 11 months
OSOM® BVBLUE® Controls (sold separately) 184 1-5mL Bottle Positive,1-5mL Bottle Negative Refrigerated 12 months
OSOM® BVBLUE® Transport Swabs 186 Room Temperature
OSOM® Vaginitis Transport Set (for use with OSOM® Trichomonas and OSOM® BVBlue) 185 Room Temperature


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® Strep A SEKISUI DIAGNOSTICS
Clear, accurate results in 5 minutes or less. Easy-to-read two color results - 50 Tests - Includes 2 additional tests for external QC. Room temperature storage - Controls included in kit.


OSOM® Strep A Test

A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.

Features and Benefits
  • Easy-to-read two-color results
  • 96% sensitivity; 98% specificity versus culture
  • Results in 5 minutes
  • CPT Code: 87880QW


Description Catalog# Configuration Storage Shelf Life
OSOM® Strep A Test 141 25-Test (plus 2 extra for external QC) Room Temperature 17 months


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® H. pylori Test SEKISUI DIAGNOSTICS
Detects IgG antibodies to H. pylori in serum, plasma or whole blood. CLIA-waived for whole blood. 95.9% sensitivity. Result in 10 minutes or less. 18 month room temperature storage.


OSOM® H. pylori Test

For the qualitative detection of Helicobacter pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection.

Features and Benefits
  • Results in 10 minutes or less
  • 95.9% sensitivity versus biopsy/histology
  • Serum, plasma or whole blood
  • Easy-to-read results
  • CPT Code: Whole blood 86318QW/Serum or Plasma 86677


Description Catalog# Configuration Storage Shelf Life
OSOM® H. pylori Test 175 25-Test Room Temperature 18 months
OSOM® H. pylori Control Kit 176 1-5mL Bottle Positive;1-5mL Bottle Negative Refrigeration 18 months


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SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OSOM® Ultra Plus Flu A&B Test SEKISUI DIAGNOSTICS
The OSOM® Ultra Plus Flu A & B Test by Sekisui 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.


OSOM® Ultra Plus Flu A&B Test

Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level

Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit.

  • High Performance
    • Equivalent to or exceeding the performance of reader devices, without the need for an instrument
  • Results in 10 minutes
  • Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals
  • Made in the USA
  • Award-winning supply chain capabilities
  • Simple CLIA-waived procedure with pre-measured extraction buffer for swab samples


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.


*Refer to the Package Insert for additional performance claims.

SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.
OraQuick HCV ORASURE TECHNOLOGIES, INC.
The OraQuick® HCV Rapid Antibody Test is the FIRST and ONLY FDA-approved, point of care test for the detection of HCV antibodies. Our simple, CLIA-waived platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes. The test can be completed in 3 simple steps from 5µl of fingerstick or venous whole blood with less than 2 minutes of hands on time.


The OraQuick® HCV Rapid Antibody Test is the FIRST and ONLY FDA-approved, point of care test for the detection of HCV antibodies. Our simple, CLIA-waived platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes. The test can be completed in 3 simple steps from 5µl of fingerstick or venous whole blood with less than 2 minutes of hands on time. It is ideal for testing programs in both clinical and non-clinical settings, as well as outreach events. Examples include urgent care, labor and delivery, laboratories and physician offices

Orasure HCV


OraQuick HCV Rapid Antibody Test
The FIRST and ONLY FDA- approved, CLIA-waived test for HCV antibodies
Accurate
  • >98% accuracy
  • Lab-accurate results

Simple
  • CLIA-waived with 3 simple steps
  • Requires less than 2 minutes of hands on time

Fast
  • 20 minutes from sample to result
  • Immediately link patients to care


ORASURE TECHNOLOGIES, INC. 220 East First Street | | Bethlehem | PA | Based in Bethlehem, Pennsylvania, OraSure Technologies develops, manufactures and markets point-of-care, oral fluid specimen collection devices that leverage proprietary oral fluid technologies, diagnostic products, including immunoassays and other in vitro diagnostic tests, and other medical devices.
OraSure Ora Quick Advance HIV-1/2 ORASURE TECHNOLOGIES, INC.
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is an FDA-approved point of care screening test for use with oral fluid, fingerstick or venous whole blood and plasma. The test delivers lab accurate results within 20 minutes with less than 2 minutes of hands on time. CDC guidelines call for routine testing in all healthcare settings to identify all HIV positive people and connect them to care.


The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is an FDA-approved point of care screening test for use with oral fluid, fingerstick or venous whole blood and plasma. The test delivers lab accurate results within 20 minutes with less than 2 minutes of hands on time. CDC guidelines call for routine testing in all healthcare settings to identify all HIV positive people and connect them to care. This simple test is ideal for testing programs in both clinical and non-clinical settings, as well as outreach events. Examples include urgent care, labor and delivery, laboratories and physician offices.

OraQuick HIV-1/2 Antibody Test


OraQuick ADVANCE HIV-1/2 Rapid Antibody Test
The early HIV antibody detection test for recent infection
Sensitivity
  • >99% accuracy
  • Comparable to 3rd generation lab-accurate results including IgM antibody detection

Versatility
  • Multiple specimen types including oral fluid, fingerstick & venipuncture whole blood, and plasma

Reliability
  • Proven performance with over 40 million tests worldwide
  • High positive predictive value; excellent specificity


ORASURE TECHNOLOGIES, INC. 220 East First Street | | Bethlehem | PA | Based in Bethlehem, Pennsylvania, OraSure Technologies develops, manufactures and markets point-of-care, oral fluid specimen collection devices that leverage proprietary oral fluid technologies, diagnostic products, including immunoassays and other in vitro diagnostic tests, and other medical devices.
cobas® Influenza A/B assay ROCHE DIAGNOSTICS
The cobas Influenza A/B assay is the first CLIA-waived, real-time PCR test to detect Influenza A and B in ~20 minutes


cobas® Influenza A/B assay

The cobas® Influenza A/B assay is the first CLIA-waived, real-time PCR test to detect Influenza A and B in ~20 minutes. Available for use in non-traditional testing sites, including ERs, physician offices, pharmacy clinics and other urgent care settings.

Benefits:
  • Lab-quality performance in the detection and differentiation of Influenza A and Influenza B
  • Fast results—20-min. turnaround time
  • Simplicity—minimal hands-on time, walk-away test with easy results interpretation
  • Supports timely, confident treatment decisions


ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways