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Negative results for symptomatic patients does not rule out the possibility of other bacterial or viral infections. This test has been validated in accordance to FDA’s guidance document:”Policy for Diagnosis testing in laboratory verified to perform High complexity testing under CLIA prior to Emergency Use Authorization for Coronavirus disease-2019 during the public health emergency issued on February 29th 2020”. This test is approved by CLIA, NJDOH and NYDOH.

Clarity Laboratory Virokey SARS CoV-2 real time PCR assay for detection of SARS CoV-2 from nasopharyngeal and oropharyngeal specimen was developed and its performance characteristics determined by Clarity Labs.

This test is only authorized for the duration of time of the declaration and for the detection of SARSCoV-2 RNS virus and/or diagnosis of COVID-19 infection under section 564 (b)(1) of the act, 21 U.S.C.360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. This assay is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA). The agent detected may not be the definite cause of this disease.

Positive results do not rule out co-infection with organisms not included in the Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1, TaqPath COVID-19 Combo Kit and/ or Panther Fusion®️ SARS-CoV-2 Assay Kit. Genesis Laboratory Testing was performed using either of the following machines Thermo Fisher TaqMan 2019-nCoV Assay Kit v1, TaqMan 2019-nCoV Control Kit v1 Test, TaqPath COVID-19 Combo Kit and/ or Panther Fusion®️ SARS-CoV-2 Assay Kit.Your test was performed using one of the machines below: If you have started Tamiflu, you may stop it. If you are negative for Flu A or Flu B and you have already taken Xofluza it is fine.If you were prescribed Xofluza or Tamiflu, you shouldn’t fill it if you’re not Flu A or Flu B positive.If you were prescribed Xofluza or Tamiflu, please start it if you are Flu A or Flu B positive.If either the rapid Covid19 antigen test (results texted or already discussed with you) or this PCR test is positive, you need to isolate as per the NJDOH quarantine guidelines.

Please refer to the NJDOH quarantine guidelines if you've been exposed or if your test is positive for Covid19.