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BELTEST-IT AGS COV-2

The BELTEST-IT AGS COV-2 Antigen Rapid Test is an in vitro diagnostic lateral flow rapid test for the direct detection of SARS-CoV-2 using sputum and saliva. It offers the ability to test a large number of patients quickly without the need for a nasal or oral swab.

PRODUCT INFORMATION

MethodImmunochromatographic assay
Specimen TypeSputum or saliva
Specimen Size10-50 mg Sputum
Time to Results15 min.
Storage Conditions2°C to 30°C
Shelf Life12 months

KIT CONTENT

  • Test cassette with test strips

  • Paper cup

  • Sample collection tube

  • Pipette

  • Instructions for Use (without illustration)

BELTEST-IT AGS COV-2: Instruction Video

CLINICAL RESULTS

Data were obtained using a total of 209 samples (103 positive samples and 106 healthy samples). Each sample was tested with both the test reagent and the gold standard reagent (RT-PCR kit). The clinical sensitivity, clinical specificity, and overall compliance rate of the test reagent are calculated based on the test results.

SENSITIVITY

92,2%

SPECIFICITY

100%

ACCURACY

96,7%

CROSS-REACTIVITY

It was tested for cross-reactivity with other diseases. All results were negative, indicating that infection with these diseases does not affect the specificity of the test.

Measles VirusMumps VirusAdenovirus Type 3Parainfluenza Virus 2MetapneumovirusHuman Coronavirus OC43Human Coronavirus 229E Influenza B virusInfluenza A (H3N2) Virus2009 pandemic Influenza A (H1N1) VirusAvian influenza A (H7N9) VirusAvian influenza A (H5N1) VirusEpstein-Barr VirusEnterovirus CA16Rhinovirus
*NOTE: Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus. Follow-up testing with an accepted reference method (e.g., RT PCR) should be considered to rule out infection in these individuals. As with all diagnostic assays, the results obtained with this test must only be used as an adjunct to other information available to the healthcare professional. Treatment of patients should be based on a combination of symptoms, clinical signs, medical history, other laboratory tests and therapeutic responses.
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