Rapid infectious disease test STREP-A TEST

diagnosticfor antigensStreptococcus A

Product overview
STREP-A is a rapid antigen test device for the qualitative detection of Streptococcus A. Supplied as a box of 20 single-pack devices for professional in vitro diagnostic use (IVD, Class B). The assay delivers qualitative results within minutes using a simple procedure suitable for trained healthcare personnel. Reagents remain stable for the indicated shelf life, including after opening.

Contents of the box

• 20 devices (single pack)
• 2 reagents
• 20 tubes and sterile swabs
• Positive and negative control solutions

Manual and languages
Multilingual manual and packaging: EN, FR, IT, ES, PT, GR, DE, SE, RO, SK

Warning
WARNING: SHORT EXPIRY DATE FOR TESTS. Typical shelf life at production is 24 months. Current stock may present remaining shelf life from 10 to 22 months.

Performance
Relative sensitivity: 95.1% (89.6–98.2%)
Accuracy: 97.1% (95.3–98.4%)
Relative specificity: 97.8% (95.8–99.0%)

Procedure (summary)

• Add 4 drops of Reagent A, then add Reagent B
• Insert swab, rotate 15 times, wait 1 minute, then remove swab while squeezing the tube to extract liquid
• Place dropper tip on top of the tube
• Add 3 drops of specimen
• Read result after 5 minutes

Ordering / packaging / regulatory identifiers
Stock availability: 3,078
Product Code: 24520
Unit of sale: box of 20 pcs
Minimum order: 1
Type: IVD - Professional Use
Class: B
RDM (NSIS): 2375791
CND: W0105090103
EAN: 8023279245202
PARAF: 987098833

Technical specifications

• Relative sensitivity: 95.1% (89.6–98.2%)
• Accuracy: 97.1% (95.3–98.4%)
• Relative specificity: 97.8% (95.8–99.0%)
• Procedure summary: add reagents A and B; rotate swab 15 times; wait 1 minute; squeeze and remove swab; add 3 drops of specimen; read after 5 minutes
• Contents: 20 devices, 2 reagents, 20 tubes and sterile swabs, positive/negative control solutions
• Unit of sale: box of 20 pcs
• Product Code: 24520
• RDM (NSIS): 2375791
• CND: W0105090103
• EAN: 8023279245202
• PARAF: 987098833
• Type: IVD - Professional Use
• Class: B