One Step Covid-19 POCT Nasopharyngeal Swab Test Kit 2019-NCoV Antigen

One Step Covid-19 POCT Nasopharyngeal Nasal Swab 2019-NCoV Antigen Rapid Test Kit

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² Fast: 15 Minutes

² Easy: One Step

² Convenient: Throat/Nasal swab sample

² Cheap: Lower cost with high efficiency

Applicable Department

Emergency Department

ICU

Pneumology Department

Cardio-Pulmonary Function Department

Intended use of Covid-19 Rapid Test

The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.

Storage & Shelf Life of Antigen Rapid Test

•  Store at 36 ~ 86 º F (4 ~ 30 º C) in the sealed pouch up to the expiration date. 

•  Keep away from direct sunlight, moisture and heat.

•  DO NOT FREEZE.

Principle of Antigen Rapid Test Cassette

After an appropriate amount of sample is added to the detection well, the sample moves under the action of the capillary. The new coronavirus antigen in the sample will combine with colloidal gold-labeled new coronavirus N protein antibody to form a colloidal gold-antigen-antibody complex. The immune complex product is then chromatographed along the nitrocellulose membrane to the detection area (T), binds to the pre-coated N protein monoclonal antibody, and forms a purple line, indicating that the new coronavirus antigen is positive.

The quality control antibody-labeled colloidal gold particles are chromatographed to the quality control area (C) and combined with the pre-coated anti-quality control antibody to form a purple C line, indicating that the test is effective. If the QC line does not appear, the test result is invalid.

Something you need to know:

Who must be tested for COVID-19?

As per the Minister’s Directive: COVID-19: Long-Term Care Home Surveillance Testing and Access to Homes (Minister’s Directive) effective January 8, 2021, all staff, student placement and volunteers working in long-term care homes must be tested regularly in accordance with the Minister’s Directive, unless the exception for individuals who have previously had laboratory confirmed COVID-19 applies. The testing requirements in the Minister’s Directive include all individuals working in long-term care homes who are: • Staff as defined in the Long-Term Care Homes Act, 2007 • Volunteers as defined in the Long-Term Care Homes Act, 2007 • Student placement, meaning any person working in the long-term care home as part of a clinical placement requirement of an educational program of a college or university, and who does not meet the definition of “staff” or “volunteer” under the Long-Term Care Homes Act, 2007. The Minister’s Directive also includes additional testing and documentation requirements for general visitors, caregivers and support workers.

When should you perform Dewei COVID-19 Ag Rapid Test?
The COVID-19 Ag Rapid test should NOT be used for diagnosis of COVID-19 infection. Any individual who is symptomatic or a contact of a confirmed case should be directed to their healthcare provider, an assessment centre, or participating licensed community lab to seek PCR testing.

How often must staff, student placement and volunteers be tested for COVID-19 with the antigen test?
Long-term care home licensees are required to conduct frequent COVID-19 testing of staff, student placements and volunteers in accordance with the protocols and frequency described in the Ministry of Health’s Provincial Testing Guidance, unless the exception in the Minister’s
Directive for previous laboratory confirmed COVID-19 applies.
• Specimen collection and screening for asymptomatic individuals in high prevalence areas (Yellow/Orange/Red/Grey) should be performed 2-3 times per week.
• Specimen collection and screening for asymptomatic individuals in low prevalence areas (Green) should be performed 1-2 times per week.
o The lower end of the frequency range would meet the compliance requirements of the Directive. However, homes are encouraged to test at a higher frequency to help reduce asymptomatic transmission of COVID-19.
Where a staff, student placement or volunteer enters a long-term care home less often than the frequency contemplated in the Provincial Testing Guidance, homes must ensure that the staff, student placement or volunteer takes an antigen test upon entry on the days on which
they are entering the long-term care home in accordance with the protocols contained in the Provincial Testing Guidance.

If an individual previously tested positive for COVID-19, should they be tested again?
An individual who has previously had laboratory-PCR confirmed COVID-19 and was cleared by the local public health unit (PHU), should generally not be re-tested for surveillance purposes due to persistent shedding. Previously cleared individuals should continue to follow
public health guidance for COVID-19 prevention, including self-isolating after high risk exposures to cases.
Re-testing after clearance should generally only be done with new the onset of new COVID-19 symptoms and can be considered if there is exposure to a confirmed case of COVID-19 or in an outbreak and/or at the direction of the local PHU. Individuals who have previously been
infected with and recovered from COVID-19 should not undergo antigen testing.