Join our ELEVATE Clinical Study today. Sign-up now

COVID-19 PCR Test

product fda neutra2 image62 dxCollec fact
product fda





icon17  Rollover to enlarge image

 

Individual patients

COVID-19 PCR Test

$95.00

The DxTerity SARS-CoV-2 (COVID-19) RT-PCR CE saliva-based test provides the convenience of at-home sample collection with results available within 24-72 hours. Our highly-sensitive, gold-standard PCR test has been verified to work with all COVID-19 variants.
 
  • Skip the lines: collect your own sample at home
  • Superior Sensitivity: Compared to antigen tests, PCR tests are up to 40% more sensitive1
  • Confident Collection: our test collects saliva,
    the preferred sample for COVID-19 Omicron variant detection2
  • Reliable Testing: DxTerity performs all testing in a dedicated,
    in-house lab for better quality control and faster turnarounds
  • Accurate Results: Even when asymptomatic, DxTerity’s
    PCR test can detect early infection with 99% accuracy
  • Fast turnarounds: Online results, typically within 24-72 hours
 
 

 

image58

fda

An FDA EUA-authorized
COVID-19 Test

Learn More

 

 

No more waiting in lines for testing. Convenient, at-home sample collection backed by accurate, reliable results.

Know your COVID-19 status in five easy steps.

No more waiting in lines for testing. Convenient, at-home sample collection backed by accurate, reliable results.

Know your COVID-19 status in five easy steps.

 

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.) 

The DxTerity SARS-CoV-2 (COVID-19) RT-PCR CE Test is an end point reverse transcription polymerase chain reaction (RT-PCR) test followed by detection with capillary electrophoresis (CE). This method of COVID-19 testing is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens collected from any individuals and is proven to be accurate even when testing those without symptoms of COVID-19. 

 

DxTerity COVID-19 PCR Test 

The DxTerity SARS-CoV-2 (COVID-19) RT-PCR CE Test is an end point reverse transcription polymerase chain reaction (RT-PCR) test followed by detection with capillary electrophoresis from saliva samples. The SARS-CoV-2 primers are designed to detect RNA from SARS-CoV-2 genome from the nucleocapsid (N) gene, envelope (E) gene, and ORF1ab region and includes an internal control for RNase P. 

Submission #: EUA202120 
Granted by FDA: 8/28/2020 
Device: DxTerity SARS-CoV-2 RT-PCR CE Test 

 


High Test Sensitivity

  • Limit of Detection at 50 virus copies / mL
  • Sensitive assay for Symptomatic and Asymptomatic Testing
  • Proven Concordance between Saliva
    and Nasal input types
  • High Throughput Chemistry

High Throughput

  • Automated Accessioning
    and Data Capture
  • Automated Sample Processing
    of Saliva Samples
  • Fast Turnaround
image64

 

Assay performance

Symptomatic patients (nasopharyngeal swab samples vs. saliva) 
Positive Agreement:   97.3% (36/37); 86.2-99.5% 
Negative Agreement: 90.0% (36/40); 76.9.7-96.0% 

Assay performance

Asymptomatic patients combined (nasopharyngeal swab samples vs. saliva)1
Positive Agreement:   84.6% (22/26);66.5-93.8% 
Negative Agreement: 99.0% (513/518); 97.8-99.6% 

  1. There were four asymptomatic individuals which tested negative by the DxTerity SARS-CoV-2 RT-PCR test and positive by the NP swab with the Roche cobas SARS-CoV-2.
    The four samples had low viral loads at the limit of detection for the cobas SARS-CoV2 assay. 

 

High concordance of saliva and nasopharyngeal swab

icon44 SDNA-1000 Saliva Collection
VS.
icon45    Nasopharyngeal Swab

 

x595

Total number of subjects tested in the study

98.2%

Asymptomatic Concordance: 584/595

image80


DxTerity asymptomatic data from EUA submission to FDA

 

icon46

Simple to use
saliva collection 

icon47

Convenient
self-collection
from home or work 

icon48

Instructions and
shipping materials
included 

 

icon49

Trusted, gold-standard
PCR testing 

icon50


Results available
in 24-72 hours 


Below are some helpful resources for you.

1
 

icon52

Order your test online

Purchase a kit online for delivery within 5 business days. Tests can also be ordered through your provider.

 

Visit our FAQs

f62fd592741b458ed56d658f2c6ec3650338bb40
 
2

icon53

Register your test kit

To register your kit, create or
log into your account, and type
in the 14-character Device ID.
The 14-character Device ID must be
entered correctly to process your test.

 

Registration video

 

image59

 

 
3

icon54

Collect your sample
and ship it to us

Follow the instructions to collect a saliva sample. Ship your sample to our lab using the pre-paid return label included in your kit.

 

Sample collection video

image60

 

 
4


icon55

Track the status
of your order

Once your order is complete, you can track your order using the tracking number in your online account.

 

Track your order

Mobile Covid
 
5

icon56

Get your results

Once your sample has been received at our lab, we will run your test and will report your results through the secure portal, all within 24-72 hours.

 

my.dxterity.com/login

image61
 

 

 

Need support?

If you need assistance setting up or accessing your account please
email This email address is being protected from spambots. You need JavaScript enabled to view it. or call ​+1-323-489-4220.
For other inquiries, please contact us.

 

Better health management begins
at home

Subscribe to receive the latest information on new developments and products at DxTerity.