Strep A Rapid Test Device by BTNX – Rapid Group A Streptococcus Detection | Test Cassettes with Controls

KEY BENEFITS

• Rapid detection of Group A Streptococcus antigens

• Results available in as little as 5 minutes

• High accuracy with 97.4% sensitivity and 99.4% specificity

• Complete kit with controls and all required materials included

WHAT IT IS / WHAT IT DOES

The Rapid Response® Strep A Rapid Test Device by BTNX is a point-of-care diagnostic test designed for the presumptive detection of Group A Streptococcus antigens from throat swab specimens. This fast and reliable lateral flow immunoassay helps support early identification of Strep A infection, enabling timely clinical decision-making and treatment.

The test is easy to use, requires no specialized equipment or training, and delivers clear results within minutes, making it suitable for clinical, pharmacy, and professional use environments.

FEATURES

• Rapid lateral flow immunoassay technology

• Results readable in 5 minutes

• No specialized training or equipment required

• Uses easy-to-collect throat swab specimens

• No cross-reactivity with 53 common respiratory tract organisms

• Includes positive and negative controls

• Mess-free setup with included plastic tube stand

• For in vitro diagnostic use only

INGREDIENTS

Medicinal / Test Components:

– Strep A test cassettes (lateral flow immunoassay)

– Reagent 1

– Reagent 2

Non-Medicinal Components:

– Sterilized throat swabs

– Extraction tubes

– Nozzles with filters

– Tube stand

– Positive control

– Negative control

KIT CONTENTS

• 20 individually packed test devices

• 20 sterilized throat swabs

• 20 extraction tubes

• 20 nozzle caps with filters

• 1 bottle of Reagent 1

• 1 bottle of Reagent 2

• 1 tube stand

• 1 positive control

• 1 negative control

• Package insert

RECOMMENDED USE

• Sample type: Throat swab

• Intended use: Aid in the diagnosis of Group A Streptococcal infection

• Read results at 5 minutes

• Use according to included instructions

PRODUCT SPECIFICATIONS

• Product code: STR-15CTC20

• Format: Cassette

• Quantity: 20 tests per kit

• Sensitivity: 97.4%

• Specificity: 99.4%

• Accuracy: 98.5%

• Time to result: 5 minutes

• Storage conditions: 2–30°C (36–86°F)

• Test principle: Lateral Flow Immunoassay

CAUTIONS / WARNINGS

• For in vitro diagnostic use only

• For point-of-care use

• Follow all instructions provided in the package insert

• Store within recommended temperature range