OSOM Strep A Rapid Test Kit 20 Tests | Professional Use

OSOM Strep A Rapid Test Kit x20

OSOM Strep A Test by SEKISUI Diagnostics is a rapid, qualitative immunochromatographic test for detecting Group A Streptococcus antigen from throat swab specimens. Designed for trained healthcare professionals and point-of-care services, the test produces a visually interpreted two-colour result in approximately five minutes.

Key Features

• Professional-use rapid antigen test for Group A Streptococcus from throat swabs
• Results in approximately five minutes after sample preparation
• Two-colour test strip interpretation
• Manufacturer-reported sensitivity of 96% and specificity of 98% versus culture, subject to the instructions for use
• Supplied as a kit for 20 patient tests, with two additional test sticks for external quality control

Kit Contents

• 20 test sticks for patient testing and 2 additional sticks for quality control
• 20 test tubes and 20 sterile throat swabs
• Extraction reagents 1 and 2
• Positive and negative control materials
• Instructions for use

Directions for Professional Use

For trained healthcare professionals only. Collect a throat swab and perform extraction and testing strictly according to the instructions supplied with the kit, including quality-control procedures and specified reading time. Interpret results with clinical assessment; a negative result does not necessarily exclude Group A streptococcal infection.

Product Specifications

• Manufacturer: SEKISUI Diagnostics
• Product: OSOM Strep A Test, CE-marked 20-test configuration
• Manufacturer part number: 141E-20
• Quantity: 20 patient tests
• Sample type: throat swab
• Test type: rapid qualitative antigen detection
• Typical result time: five minutes after extraction
• PIP: 8011827

Frequently Asked Questions

Is this a home self-test? No. The kit is intended for professional in vitro diagnostic use by trained personnel.

How many tests are supplied? The kit provides 20 patient tests and additional sticks for external quality control.

Does a negative test rule out Strep A? Not necessarily. A negative result must be interpreted with clinical findings and follow-up testing where clinically indicated.

Cautions and Storage

• For professional in vitro diagnostic use only; not for self-testing
• Use appropriate infection-control precautions when collecting and handling specimens
• Reagents contain chemical substances; follow the manufacturer's handling and safety instructions
• Do not use after the expiry date or if packaging is damaged
• Do not interchange components between kits unless expressly permitted by the manufacturer
• Store at the temperature specified in the instructions and do not freeze
• Dispose of used swabs, test strips and reagents according to clinical waste procedures