Infectious Disease

Status™ Covid-19 Antigen Rapid Test For Home Use

Rapid Immunoassay for the Direct Detection of SARS-Cov-2 Antigen for use with anterior nasal specimens for at home use.

FDA Emergency Use Authorization (EUA)

  • Visually Read in 15 minutes
  • For Home Use, Workplace Testing, Schools
  • Ages 14 years and older
  • Ages 2 years and older when specimen collected  and tested by an adult.

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
Status™ Covid-19 Antigen Rapid Test For Home Use 33301 1 EUA
Status™ COVID-19 Antigen Rapid Test For Home Use 33302 2 EUA
Status™ COVID-19 Antigen Rapid Test For Home Use 33325 25 EUA

Status™ Covid-19/Flu A&B

A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens 

COVID-19

  • Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
  • Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
    Flu A - Sensitivity 91.4%, Specificity 95.7%
    Flu B - Sensitivity 87.6%, Specificity 95.9%
    FDA Emergency Use Authorization (EUA)
    Visually read in 15 minutes
    Flocked nasopharyngeal swab for superior specimen collection and patient comfort

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
Status™ Covid-19/Flu A&B 33225 25 EUA

BioSign® Flu A&B

An in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens

  • CLIA WAIVED for nasal swab and nasopharyngeal swab specimens
  • Rapid diagnosis for early treatment
  • Innovative flip test design
  • Easy-to-read cassette
  • Pre-measured extraction reagent capsule for increased accuracy and ease of use
  • Flocked nasal swabs included for better specimen collection
  • Detects H1N1 (Swine Flu)

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® Flu A&B BSP-510 25 √​ √​ √​

Status® Strep A – Flip

Rapid Detection of Group A Streptococcal Antigen
Directly From Throat Swab Specimens

  • External positive and negative controls included
  • Single use reagent capsules
  • Positive results in 5 min
  • Sensitivity 96%, specificity 99%
  • No counting reagent drops – fewer steps for greater accuracy

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
Status® Strep A – Flip BSP-182 25 √​ √​ √​

BioSign® Strep A

Rapid Detection of Group A Streptococcal Antigen
Directly From Throat Swab Specimens

  • Cassette format
  • Simple procedure
  • Sensitivity 96.2% , Sensitivity 98.7%
  • Results in 5-10 minutes
  • External Controls included in kit

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® Strep A BSP-181 25 √​ √​ √​

BioSign® H. pylori IgM/IgG/IgA

For the qualitative detection of anti-Helicobacter pylori antibody in human whole blood, serum, or plasma specimens.

  • Requires only 25 μl of whole blood or 10 μl serum/plasma
  • Single-reagent procedure

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® H. pylori IgM/IgG/IgA BSP-406WB 35 whole blood √​ √​

BioSign® H. pylori Control Set

Status H. pylori Control set are external controls to monitor the performance of the Status H.pylori test devices. The set contains a positive and a negative serum controls for qualitative use.

  • Liquid- Ready to use
  • Convenient plastic dropper tip vials

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® H. pylori Control Set 200013 2 x 1 mL

BioSign® Rubella IgG

Immunochromatographic  assay for the qualitative detection of anti-Rubella Antibody (IgG) in human serum or plasma.  Use as an aid in the determination of immune status or for the confirmation of recent rubella infection.

  • Rapid results in 15  minutes
  • Easy to use – in office testing
  • Accurate results

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® Rubella IgG BSP-171 35 √​ √​

BioSign® Mono IgM

For the Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Whole Blood, Serum or Plasma 

  • Results within 8 minutes
  • FDA cleared with no age restrictions
  • Single reagent procedure provides results in 3-8 minutes
  • Superior 99.9% sensitivity for earlier IM detection, specificity of 98.8%
  • External QC negative and positive controls included

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioSign® Mono IgM BSP-402WB 35 whole blood √​ √​

BioStrep® Strep A

Rapid Detection of Group A Streptococcal Antigen Directly from Throat Swab Specimens

  • Strip format
  • Simple procedure
  • Sensitivity 96.2% , Sensitivity 98.7%
  • Results in 5-10 minutes
  • External Controls included in kit

Ordering Information

Product Catalog # Kit Size CLIA Waived FDA CE
BioStrep® Strep A BSP-185 25 √​ √​ √​