IME® SARS-CoV-2 Ag SALIVA RAPID TEST
Listed by BfArM Germany*
Test-ID: AT524/20
(enter the number into the search box of the BfArM register)
*Federal Institute for Drugs and Medical Devices
Intended use
IME® SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human saliva. The test is for in vitro diagnostic use only.
Proven Quality by Study Reports*
Sensitivity: 98.26 %
Specificity: > 99.99 %
Accuracy: 99.50 %
* A total of 603 specimens are tested using the IME® SARS-CoV-2 Ag Saliva Rapid Test.
These specimens are obtained by saliva from symptomatic patients. The performance of the IME® SARS-CoV-2 Ag Saliva Rapid Test is compared to a commercialized molecular assay.
Specific Characteristics
Non-invasive
Pure saliva test: No complicated smear tests from the nose or throat are necessary to collect samples. No risk of injury for patients.
Long Shelf Life
Stored at room temperature or cooled down
(2 °C – 8 °C), the samples can be used up to
24 hours without influencing the test results.
(Sample Stability Study Report).
Uncomplicated
The giving of the saliva sample is easy for both children and adults.
Massive time savings for testing
Sample collection within a very short time. Serial testing possible.
No risk of injury for patients
No necessity of sampling by a smear test. The sampling is made by collecting the saliva in the personal collection cup.
Higher safety for medical staff
Proband provides the sample himself. There is no closer contact between the test person and test staff.
Advantageous personnel management:
Lower number of required staff enables the medical team to be deployed more efficiently.
Cost savings
in safety clothing and protective equipment possible.
Package Content
1) 15 Test Devices
2) 15 Extraction Solutions
3) 15 Extraction Tubes
4) 15 Extraction Tube Tips
5) 15 Collection Cups
6) 15 Pipettes
7) 1 Tube Stand
8) 1 Package Insert
Instruction Video
Downloads
IME® SARS-CoV-2 Ag SALIVA RAPID TEST
Instruction for use
(PDF | about 0.6 MB | Status: 2021-01)
IME® SARS-CoV-2 Ag SALIVA RAPID TEST
Data Sheet
(PDF | about 0.2 MB | Status: 2021-01)