InTec Rapid SARS-CoV-2 Antigen Test receives CE mark for self-testing May 10, 2022

InTec, a global leading IVD company specialized in infectious disease diagnostics with a focus on screening at the point of care, has announced that its Rapid SARS-CoV-2 Antigen Test has been CE marked for self-testing. The test will be available in countries accepting the CE mark, in packs of 1/2/5/7/25 tests.

The InTec Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced rapid immunochromatographic

assay for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. This test is authorized for home use with self-collected anterior nasal swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision. The test can also test specimens from individuals without symptoms.

  • Specimen: Anterior Nasal swab specimens
  • Testing Time: 15-20 minutes
  • Performance: 93.64% sensitivity and 100% specificity when compared with RT-PCR
  • Storage Temperature: 2-30 ℃
  • Shelf life: Up to 24 months
Performance Characteristics

PCR

Positive

Negative

Total

Rapid SARS-CoV-2 Antigen Test

Positive

103

0

103

Negative

7

470

477

Total

110

470

580 


Results analysis

Sensitivity: 103/110=93.64%

Specificity: 470/470=100.00%

Total coincidence rate: 573/580=98.79%


Ordering Information 

Product

Cat. No.

Type

Pack Size

Specimen

Certification

Rapid SARS-CoV-2 Antigen Test for self-testing

ITP16030-TC1

Cassette

1T

Nasal swab

CE

ITP16030-TC2

Cassette

2T

Nasal swab

CE

ITP16030-TC5

Cassette

5T

Nasal swab

CE

ITP16030-TC7

Cassette

7T

Nasal swab

CE

ITP16030-TC25

Cassette

25T

Nasal swab

CE



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