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AMP Rapid Test SARS-CoV-2 Ag

AMP Rapid Test SARS-CoV-2 Ag is a rapid immuno-chromatographic test for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human nasal or throat swab samples as an aid in quick and efficient diagnosis of Corona Virus Disease 2019 (COVID-19).

The test is easy to use and can be performed even without the availability of laboratory environment. Results are available within 15 minutes.

Clinical studies in comparison with RT-PCR evidenced high sensitivity and specificity of the test.

Test temporarily approved for self testing by German BfArM - file number 5640-S-062/21

Kit composition:

Sealed test pouch (1 or 10 pieces)

including:

test cassette

desiccant (for storage purposes only)

Sterile swab
Pre-filled buffer tube
Disposal bag
Tube holder

According to the usability study, this test is suitable for self testing by adults and children aged 11 or older.

Download Instructions for Use for professional use (click PDF symbol)

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Download Instructions for Use for self testing (click PDF symbol)

Kit composition:

Sealed test pouch (25 pieces)

including:

test cassette

desiccant (for storage purposes only)

Sterile swab
Sample tube and dropper tip
Extraction buffer
Tube holder

*) Kit includes pre-filled buffer tubes

Illustrated description of the test procedure included in the test kit and available on request

AMP Rapid Test SARS-CoV-2 Ag - self testing

Cat.No.

Kit content

Test principle

Sample material

Sample volume

Assay time

Sensitivity

Specificity

RT2950

1 cassette

RT2951

10 cassettes

immuno-chromatographic

anterior nasal swab

appr. 100 µL of extracted sample

15 minutes

97.3%

100%

AMP Rapid Test SARS-CoV-2 Ag - professional use