DATA & FACTS

PERFORMANCE CHARACTERISTICS

Diagnostic sensitivity and specificity:

In an internal study, a group of 2459 samples, the results of which had previously been confirmed with the RT-PCR method, were tested with the COVID-19 antigen test kit. COVID-19 RT-PCR positive at ≤ 25Ct were taken for testing. The results obtained are as follows:

Analytical sensitivity:

The COVID-19 antigen test kit can detect a concentration of only 0.78 ng / ml COVID-19 N antigen.

Analytical specificity:

Cross-reactivity: The potential cross-reacting infections / diseases / conditions like HBsAg, HCV, Dengue, Syphilis, HIV, Rheumatoid Factor and other related Covid strains like Coronavirus 229E, OC43, HKU1, NL63, SARS and MERS did not affect the performance of the COVID-19 Antigen test kit.

Interference:

The following potentially interfering substances did not affect the performance of the COVID 19 Antigen Test Kit:

Human anti-mouse antibodies, mucin, biotin, coronavirus 229E, OC43, HKU1, NL63, SARS, MERS, Adenovirus, Influenza A, B, RSV, Rhinovirus, C. Pneumoniae, H. Influenzae, L. Pneumophila, St. Pneumoniae , St. Pyrogen, My.Tuberculosis, B.Pertusis, PJP, C.Albicans, Pseudomonas aeruginosa, Stap. Epidermis, stap. Salivaris. Bilirubin (40 mg / dl), hemoglobin (1000 mg / dl), triglycerides (2000 mg / dl) and total protein (15 g / dl).

Acetaminophen (1030 µmol / l), Alpranjolam (0,835 µmol / l), Ascorbic acid (298 µmol / l), Biotin (4250 ng / ml), Captopril (12,1 µmol / l), Fluoxetin (4,59 µmol / l) L), Guaifenesin (22,7 µmol / l) and Hydroxychloroquin (388,8 ng / ml).

Precision:

Within the run (repeatability) and between runs, the precision (reproducibility) was determined by testing strongly positive, moderately positive, and weakly positive control samples in 3 replicates with 3 different lots of the COVID-19 antigen test kit. The samples were correctly identified in each run and show 100% accuracy.

RESTRICTIONS

  • This test detects the presence of antigen against the novel coronavirus 2019 (SARS-CoV-2) in the nasal specimens and should not be used as the exclusive criterion for the early detection of COVID-19.

  • If the test result is negative and clinical symptoms persist, additional follow-up tests using other clinical methods are recommended. A negative result does not rule out the possibility of early infection with COVID-19.

  • For professional use only. The test results may be affected by an inappropriate sampling of the specimen.