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.

Play Video

Resource Files

↓ Status™ COVID-19 Home - Test Procedure

↓ Status™ COVID-19 Home - PI - Home User

↓ Status™ COVID-19 Home - PI - HCP

↓ Status™ COVID-19 Home - Fact Sheet - HCP

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

Play Video

Resource Files

↓ Expiration Dating Memo

↓ Status™ COVID-19/Flu Package Insert

↓ Status™ FactSheet Healthcare Providers

↓ Status™ FactSheet Patient

↓ Status™ COVID-19/Flu SDS

↓ Status™ COVID-19/Flu Procedure Card

↓ Status™ COVID-19/Flu Sell Sheet

↓ Status™ Flu A&B Annual Reactivity Testing Results

↓ Status™ COVID-19/Flu CLSI

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)

Play Video

Resource Files

↓ BioSign® Flu A+B Package Insert

↓ BioSign® Flu A+B SDS

↓ BioSign® Flu Annual Reactivity Testing Results

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

Play Video

Resource Files

↓ Status® Strep A Flip Package Insert

↓ Status® Strep A Flip SDS

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

Resource Files

↓ BioSign® Strep A SDS

↓ BioSign® Strep A Package Insert

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

Resource Files

↓ BioSign® H. pylori Package Insert

↓ BioSign® H. pylori SDS

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

Resource Files

↓ BioSign® H. pylori Control Set SDS

↓ BioSign® H. pylori Control Set Package Insert

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

Resource Files

↓ BioSign® Rubella SDS

↓ BioSign® Rubella Package Insert

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

Resource Files

↓ BioSign® Mono SDS

↓ BioSign® Mono CE Package Insert

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

Resource Files

↓ BioStrep® A SDS

↓ BioStrep® A Package Insert