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The process to perform COVID-19 testing is simple and convenient with Eurofins Genomics. However, it helps to familiarize yourself with the details of the process beforehand to ensure a smooth experience.

First, it is important to understand the terminology.

  • Client refers to the institution ordering the test, e.g. a retirement home.
  • Physician refers to the doctor or health professional who is authorized to order the test. Some states do not require a physician's order for COVID-19 testing, while others do. Also, the physician may or may not be associate with the client. For instance, a hospital would use their own physician to order a test, while a manufacturing company may use an external physician. Eurofins can help in this area if a physician is needed.
  • Patient refers to the person being tested.
  • Practice refers to the testing lab, e.g. Eurofins Genomics.

Secondly, consider the question of whether you are looking for group testing or individual testing. Both are self-explanatory. Group testing revolves around repeat testing for an organization. For instance, schools, sports teams, and manufacturing all require repeat testing to continue operating. The same principle applies to a myriad number of industries. Individual testing refers to a single person. Please visit the EmpowerDx website for self collection kits for individuals.

Tests Offered by Eurofins Genomics

Nasopharyngeal (NP Swab) Nasal Saliva
  • Highest reliable
  • Highest accuracy
  • Most common
  • Convenient
  • High accuracy
  • Very convenient
  • Moderate accuracy

Additional Testing Methods from Eurofins

Eurofins is a collection of labs that operate autonomously. Additional testing methods are validated at other clinical labs, including the following COVID-19 tests:

  1. Self Collection test
  2. Antibody test
  3. Flu+COVID-19 test
  4. Facemask test
  5. Surface testing
  6. Pooling

If you wish to use a different collection method than the options shown above, we are happy to connect you with another Eurofins lab.

Documents

Test Validation

The SARS-CoV-2 reverse transcriptase real-time PCR (rRT-PCR) test is a laboratory-developed test (LDT) intended as a diagnostic aid to confirm the presence of SARS-CoV-2 RNA extracted from nasopharyngeal, nasal, or oropharyngeal swab specimens collected from human patients. Validation studies showed that this test detected SARS-CoV-2 RNA at or above 35 copies/mL with 99% accuracy and 99% precision. The performance characteristics of this test were determined by the Eurofins Applied Genomics Louisville clinical laboratory which is regulated under CLIA as qualified to perform high-complexity testing.

The presence of SARS-CoV-2 RNA below 35 copies/mL is not ruled out. The results of the SARS-CoV-2 rRT-PCR test are not intended to be used as the sole means for clinical diagnosis or patient management decisions. Patient counseling and informed consent are recommended for SARS-CoV-2 rRT-PCR testing. 

 

Testing with Eurofins Genomics is easy. Orders are placed online through our convenient patient portal named CareEvolve. CareEvolve functions as a database for adding patients and managing patient testing at your organization. Eurofins will set up an administrator account for your organization. The admin will manage the testing schedule by submitting orders for tests.

We recommend reviewing the terminology outlined in the first tab to best understand the directions below.

 

Add Patients

1. Admin will receive an email with a username, location, and temporary password to change after successful login.

2. Users will login at https://eurofins.careevolve.com/

3. Add a patient to Care Evolve if the patient does not already exist in the system. If adding multiple patients, you can upload an excel file.

           - Click Add Patient or Upload Patient Roster under the Patients tab

 

4. If adding an individual patient, the next step is completing the required patient demographics, highlighted in red.

 

5. Save when done. If you are ready to test that patient, click Save and Place Order.

 

Order Test

An order equates to a patient test. The account admin will submit orders to manage the testing process.

1. Select the patient you wish to order a test for. This can be done by searching for the patient in the system or selecting them from the list.

2. Click the "create new order" button

3. Select the ordering physician and click next.

4. Search for the test name, select it, and click next. The test name will be given to you during the on-boarding process.

5. Answer the required AOE questions

6. Review all information. The priority is routine. Click the complete button when finished.

7. Print the order confirmation page.

8. Attach 1 of the 4 barcodes found at the bottom of the confirmation page to the  sample tube. You do not need to attach all 4 barcodes. Eurofins can provide custom printer paper if needed.

9. After barcoding the tube, fold the order confirmation page and place it inside the baggie with the matching patient's sample tube.

10. Once all samples are collected and orders placed, ship the sample baggies to:

Eurofins Genomics LLC, Applied Genomics Lab
12701 Plantside Dr.
Louisville, KY 40299

 

The directions shown below demonstrate the proper process for collecting samples using a nasopharyngeal (NP) swab. For additional collection methods, such as nasal or saliva, please refer to the CDC instructions.

FINAL STEP: place the sealed tube and order form, which is printed from the online portal, inside the plastic baggie and send to our lab. 

 

Documents and Additional Collection Methods

Collecting samples requires a steady supply of swabs, bags, and sometimes paper requisition forms depending on the situation. In addition, Eurofins typically includes informational pamphlets on HIPAA, collecting samples, and general tips. For larger contracts, supplying these materials each week can be a significant effort and cost. In most cases, Eurofins provides these supplies free of charge as long as the number of resulted samples correlates with the supplies.

Current customers can request additional supplies by emailing GenomicsSupport@eurofins.com.

FAQ

Does Eurofins test detect the variants?

Eurofins is continuously monitoring open access genomic data coronavirus databases and running tests to make sure our SARS-CoV-2 panel is capable of detecting the virus. In our most recent analysis of 244,805 GISAID SARS-CoV-2 sequences, 99.4% demonstrated 100% identity to both forward and reverse primers and the probe for at least one of the primer/probe sets in our panel.  To address the impact of the variants that did not show 100% identity, we have developed synthetic molecules representing variants to challenge our SARS-CoV-2 panel primer and probe sets. To this end we have found that our primer and probe sets are still capable of detecting a change common to variants from Brazil, Italy, Russia, South Africa India and USA (WA-S2280/202). Tests are currently underway to determine if the recent variants from England and the US impact our test. Fortunately at least one or more probes in our panel are a 100% sequence match for both the England (UK) and US variants. Early testing indicates that it is 99.96% effective for the South African variant.

Furthermore, it is important to clarify a few points about variants. First, viruses constantly evolve. Variants, such as base mutations, began from the very onset of SARS-CoV-2 virus. However, a vast majority of these variants do not impact the virus in any significant way. The UK and South African  variants made headlines, and as a result expanded the international discussion around variants, because they impacted how the virus spreads.

 

What is the difference between an LDT and EUA?

Over the course of 2020, the public heard a lot about EUA (Emergency Use Authorization) tests, so it may help to clarify the differences between an LDT and EUA. In essence, EUAs were a mechanism used by the FDA to quickly meet the need for increased testing in the United States. The normal FDA approval process for clinical laboratory tests involves a long timeline, but EUAs were a "fast track" method to expand testing and counter the spread of the virus.

Which is better?

The differences are negligible. Both tests accomplish the same goal which is to validate an accurate, reliable test for human samples. When EUAs were gained popularity in 2020, some scientists were skeptical that they would be as accurate or precise given the quicker approval process. LDTs were perceived as slightly more accurate at that time, i.e. the "tried and true" method prevailing over the novel. However, that perspective balanced out over time. Many laboratories have developed some truly wonderful EUA-approved tests and made their work available in the public domain. This collective effort rapidly popularized EUAs and at the same time exposed these protocols to a great degree of scrutiny from other labs, proving their accuracy and precision. In conclusion, both tests are viewed as highly accurate and reliable test for verifying the presence of the SARS-Cov-2 genome. Eurofins Genomics chooses to use an LDT, but many labs even within our own Eurofins network offer an EUA as well.

 

Do I need a physician's order to get tested?

It depends on the state where the sample is being collected. In Kentucky for example, the requirement for a physician's order has been waived. Many other states still require a physician's order though. Please check the requirements in your state.

 

What is the difference between an LDT and EUA?

Over the course of 2020, the public heard a lot about EUA (Emergency Use Authorization) tests, so it may help to clarify the differences between an LDT and EUA. In essence, EUAs were a mechanism used by the FDA to quickly meet the need for increased testing in the United States. The normal FDA approval