FDA Fact Sheet - Patients

FDA Fact Sheet - Health Care Providers

 

To support COVID-19 diagnosis and confirmation we offer a high-complexity molecular real-time PCR Covid-19 test.

 

Test Summary

Test Name:

Severe Acute Respiratory Syndrome-Related Coronavirus 2

Alias:

COVID-19; SARS-CoV-2; 2019 Novel Coronavirus

Classification:

Authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

Methodology:

RT-PCR

Reference Range:

Negative

Result Interpretation: 

  • Positive (Detected) - results are indicative of an active infection with SARS-CoV-2 but does not rule out other bacterial infections or co-infection with other viruses.
  • Negative (Not Detected) - results indicate that SARS-CoV-2 was not detected in the specimen. However, a low level below the level of detection of SARS-CoV-2 could be possible. In addition, this result does not rule out the possibility of other bacterial infection or infection with other viruses.

Specimen (Preferred):

Anterior Nasal Swab (Dry)

Transport Temperature:

Frozen

Storage Condition:

Room Temperature - up to 12 hours

-20 degrees Celsius - up to 2 days

Turn Around Time:

Standard - 24 hours

STAT/RUSH - less than 6 hours of sample(s) being received in the lab 

 

COVID-19 Molecular Test

Real-time PCR provides an accessible, high-throughput testing option. SARS-CoV-2 RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human nasopharyngeal swab, anterior nasal swab and mid-turbinate nasal swab specimens from individuals suspected of COVID-19. 

 

Results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection.

 

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results 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.

 

The US FDA has granted Emergency Use Authorization (EUA) for Bio-Rad's SARS-CoV-2 ddPCR Kit in the US.*

 

Note: $50.00 fee applied to returned payments.

PICK-UP - Bio-Rad Real-Time PCR COVID-19 Test

$100.00Price