Products Description
Individual Speichel Antigen Test 19 Certificate Antigen Buffer Test Tube bfarm German Antigen Rapid Test Kit Cassette
Specimen types | Nasal Swab or Throat Swab |
Testing time | with in 20 minutes |
Accuracy | 99.09% |
Brand | iClean |
Packaging | 1 Set/Box |
Place of origin | China |
Certificate | CE/ISO13485/TGA |
Specification
【INTENDED USE】
Negative results do not rule out infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with, and confirmed with a molecular assay, if necessary for patient management.
【WARNINGS AND PRECAUTIONS】
· For in vitro diagnostic use only. · Do not use this product as the sole basis to diagnose or exclude infection or to inform infection status. · Do not use this product after the expiration date. · Please read all the information in this leaflet before performing the test. · The test cassette should remain in the sealed pouch until use. · All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. · The used test cassette should be discarded according to federal,state and local regulations.
【COMPOSITION】
Materials Provided · 1 Test Cassettes: each cassette packed in individual foil pouch · 1 Sterilized Swabs: single use swab for specimen collection(nasal or throat swab, according to your need) · 1 Dropper with extraction reagents Materials Required but not Provided · Timer
Instructions
High Accuracy
The accuracy is up to 99.09% according to the clinical performance
Ag Rapid Test | PCR(CT value<30) | ||
Positive | Negative | Total | |
Positive | 100 | 1 | 101 |
Negative | 4 | 448 | 452 |
Total | 104 | 449 | 553 |
Sensitivity | 96.15% (100/104, 95%CI, 90.86%~99.69%) | ||
Specificity | 99.78% (448/449 95%CI, 97.75%~99.66%) | ||
Accuracy | 99.09% (548/553 95%CI, 97.73~99.58%) | ||
Main Items
A variety of swabs are available, please choose according to your needs; the latest design simplifies the testing process and provides more convenient and fast testing
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