Антиген RTK Home 19 iClean, высококачественный набор для тестирования антигена, быстрый тест антигена для детей

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Products Description


RTK Antigen Virus Test Home 19 iClean High Quality Swab Antigen Test Kit Antigen Rapid Test Kid


Brand
iClean
Specimen types
Throat swab or Nasal Swab
Testing time
20 minutes
Accuracy
99.09%
Packaging
25 Sets/Box
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 forpatient 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
· 25 Test Cassettes: each cassette packed in individual foil pouch
· 25 Sterilized Swabs: single use swab for specimen collection(nasal or throat swab, according to your need)
· 25 Dropper with extraction reagents
Materials Required but not Provided
· Timer


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




Instructions


Instructions of the detection process
Operate according to the requirements, you can simply complete the test




Our Partners




Class 100,000 GMP Factory&Lab




Exhibition




Certifications




Packing&Delivery




0.0155 s.