Singclean COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromotographic assay for the rapid, qualitative detection of antigen from COVID-I 9 in human nasal swab specimen. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings. Features: Results ready in 15 minutes Accurate diagnostic tool for active infection Easy to administer and read results Affordable, no need for instrument, highly portable Enable testing on a massive scale Storage and Stability The kit can be stored at room temperature or refrigerated (4-30�°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date. Limitation: 1. Use fresh samples whenever possible. 2. Positive results do not rule out bacterial infection or co-infection with other viruses. 3. A negative result can occur if the quantity of the COVID-19 antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19 antigen in the nasal cavity of the patient. 4. Negative results do not rule out infection with COVID-I 9 and should not be used as the final of sole basis for treatment or patient management decisions. Negative results should be considered in the context of a patients recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-I 9. For a more accurate test result, repeat the tests or confirmed with other testing methods and clinical findings is recommended. Warnings: Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Inadequate of inappropriate sample collection, storage, and transport may cause false test results.
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