COVID-19 qPCR Testing

NEXT is pleased to offer COVID-19 testing.  The assay being utilized is a modified CDC SARS CoV2 rtPCR assay for detection of COVID19, for which NEXT has applied for Emergency Use Authorization (EUA) from the FDA.  The cash price for this assay is $150.

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Next Bio-Research has submitted and is under review by the FDA, an Emergency Use Authorization (EUA) request for use of a SARS-CoV-2 molecular diagnostic test to be performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in respiratory samples from patients as recommended for testing by public health authority guidelines.

The SARS-CoV-2 assay is a real-time RT PCR (rRT-PCR) assays for the in vitro qualitative detection of 2019-Novel Coronavirus (2019-nCoV) in respiratory specimens intended for the presumptive detection of nucleic acid from the SARS-CoV-2 in nasal pharyngeal swabs taken from individuals suspected of COVID-19. Testing is limited to laboratories that are Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratories.

Results are for the [presumptive] detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection with SARS-CoV-2 but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

SARS-CoV-2 Total Antibody Testing

NEXT is pleased to announce the launch of the “Platelia” SARS-CoV-2 Total Antibody Assay. This is a one-step antigen capture ELISA which is intended for use as a qualitative in vitro diagnostic test. The ELISA measures the presence of total antibodies (IgG/IgM/IgA) in human serum or EDTA plasma samples which are directed against the Cov2 virus.  The Platelia assay was commercialized by Bio Rad Inc and has received Emergency Use Authorization from the United States Food and Drug Administration (FDA).  

• As is the case with all serological tests for CoV2, clinical diagnosis of Covid 19 should not be established on the basis of the Platelia assay result; follow up and supplemental testing as well as other clinical and laboratory data should be considered.

• A negative result in the Platelia assay does not rule out Cov2 infection, particularly in individuals who have been in contact with the virus.  Follow-up testing with a molecular diagnostic should be done to rule out infection in these individuals.

• A negative or non-reactive result in the Platelia assay can occur if the quantity of antibodies for the Co2 virus is below the detection limit of the assay. In addition, during the acute infection phase, or in immunocompromised patients, anti-Cov2 antibodies might not be detectable.

• The Platelia assay can detect antibodies to SARS-Cov1 and a cross reaction with antibodies to MERS-CoV is also possible.

The L-asparaginase assay is a laboratory developed test (LDT) to determine the enzyme activity of L-asparaginase in patients who have been treated with Elspar®/Kidrolase®, Oncaspar®, or Erwinaze®. This assay has been validated and is performed in our CLIA certified laboratory to monitor the asparaginase activity level during a patient’s treatment.

Because our genetic makeup is not all the same, the way that we each metabolize medications is not all the same.  NEXT Molecular Analytics provides genetic testing to supply to a physician to guide treatment of their patients.