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Description
Box of 25 TESTING PANBIO Ag RAPID TEST DEVICE FOR DETECTION OF ANTIGEN
25 persons can be tested with this box
• Quick response =====> 15 minutes • Reliable, high performance* – Sensitivity: 91.4% (94.1% for samples with Ct values ≤33) – Specificity: 99.8% • Possibility of implementing a Point of Care in several units, decentralizing the testing • Affordable solution that enables large-scale testing
• PANBIO COV ID -19 AG
Other variant of the Panbio
– CATALOG NUMBER: 41FK1s (Nasal Swab) - 25 tests/kit • CONTENTS: 25 test devices, 1 buffer (9 ml/vial), 25 extraction tubes, 25 tube caps extraction, 1 positive control swab, 1 negative control swab, 25 sterile nasopharyngeal swabs for collection sample, 1 tube holder, 1 quick reference guide, 1 instruction for use.
PERFORMANCE AND SPECIFICATIONS
INTENDED USE: In vitro Rapid Diagnostic Tests for the qualitative detection of C antigen (Ag) in human nasopharyngeal swab samples from individuals.
The Panbio Ag Rapid Test Device is intended for professional use only
The product can be used in any laboratory and non-laboratory environment that meets the requirements specified
in the Instructions for Use and local regulations. The test provides only a preliminary result.
Negative results do not exclude the possibility of infection especially with Omicron.
Negative results must be combined with observations, history and contact information.
• SENSITIVITY: 91.4% (94.1% for samples with Ct values ≤33)
• SPECIFICITY: 99.8%
• CLINICAL STUDY POPULATION:
585 subjects, including 140 with positive PCR tests and 445 with negative PCR tests • TEST TIME: 15 MINUTES
• STORAGE: 2°C–30°C
• SAMPLE TYPE: Nasopharyngeal Swab
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