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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.
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 |