Testing for COVID-19

By dedicating our laboratory resources and working with both state and federal health agencies, we are working together in the fight against the COVID-19 pandemic.

Our COVID-19 testing is part of a national effort to identify and treat active cases of the disease. The test is meant for those individuals meeting the updated guidance of the CDC for diagnosing and treating infections with COVID-19.

Utilizing the skills acquired through state-of-the-art molecular testing, our goal is to assist in the containment of this public health crisis and end the risk of this disease. If you need more information about the COVID-19 test that NOAH Clinical Laboratory provides, please contact our support staff at 414-600-1020.

Information for Providers Who Wish to Order Tests

NOAH Clinical Laboratory detects the virus that causes COVID-19, SARS-CoV-2 RNA, using a real-time RT-PCR test. The test is done on specimens from the upper respiratory tract and shows if the virus is present or not.

Due to the emergency nature of the COVID-19 pandemic, the test we use has not received standard FDA clearance or approval, rather, it is currently pending approval under an emergency use authorization by the FDA; this emergency use is limited to authorized high complexity laboratories, such as our own.

The COVID-19 test is currently detecting SARS-CoV-2 nucleic acids only, and does not detect any other pathogens, viral or bacterial. The PCR test we use will be valid so long as the FDA determines that the conditions of the pandemic warrant its use. The use of this test for diagnostic tests in vitro is authorized for detection and diagnosis under the following section of FDA rules.

Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) The authorization is current and will run until it is revoked or terminated by the FDA.

Services to Healthcare Providers

COVID-19 tests are available to healthcare providers who have an active account with us. Individuals wanting tests for COVID-19 should check with their own healthcare providers or follow the advice from the health department in their area, regarding testing locations.

In Wisconsin, healthcare organizations and providers need to go to the Wisconsin state website to arrange testing, and to request supplies for testing. The site is as follows:

https://covid19supplies.wi.gov/Testing

The Process for Testing

Collecting a Sample

You can collect a sample using any of the CDC or FDA-recommended methods for upper respiratory collections:

  • NP (Nasopharyngeal)
  • Anterior Nasal (Nasal)
  • OP (Oropharyngeal)
  • Mid-turbinate

We follow recommendations by the CDC and FDA which require that samples are obtained by use of synthetic-tipped swabs with either aluminum or plastic shafts. Please do not use swabs with wooden shafts, cotton tips, or that use calcium alginate as a preservative. Transport media can be any of the following:

  • VTM (viral transport media)
  • UTM (universal transport media)
  • RNA-free saline
  • Amies

You can find FDA answers to frequently asked questions (FAQ) regarding Diagnostic Testing for SARS-CoV-2 at the following site:

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2

This above information is current as of March 21st, 2021.

Collection Supplies

Our lab is happy to provide collection and transportation supplies for COVID-19 testing; these include a plastic shaft, synthetic-tipped swab, as well as RNAse-free transport media. Our supplies can be used for all methods of collection.

Handling Specimens and Shipping to NOAH Clinical Laboratory

There are several important and necessary steps to follow in order to get the best results from your testing. Specimens need to be properly labeled with patient information so that our we can report test results properly. In addition, collection information needs to be precise, and handling must be correct so that the specimen arrives at our laboratory in a condition that allows for accurate test results.

Criteria for Accepting Specimens

Necessary patient information for patient identification:

  • Patient Identification Elements
  • Legal First Name
  • Legal Last Name
  • Birthdate

We will only accept and process specimens for which the required information is clear on the collection device and requisition form, or in the order required by our electronic interface.

Elements of collection

  • Specimen Collection Date
  • Specimen Collection Time

If you do not provide a time of collection, we will revert to 12:00 AM on the collection date specified for determining stability.

Elements of Specimen Transport

  • Samples must arrive at our lab within 48 hours of when they were collected.
  • Specimen tubes need to be intact with no leaking or obvious contamination.

Instructions for Delivery of Specimens

Send specimens to:

NOAH Clinical Laboratory
10501 W. Greenfield Ave.
West Allis, WI 53214

For hand delivery, contact us at Support@NOAHClinicalLaboratory.com or call 414-600-1020 for instructions.

Delivery of Results

We provide test results for COVID-19 to the provider who ordered the test, over our secure electronic portal; patients also have access to their results via the electronic patient portal.

Results are reported to the appropriate state health department, following their requirements for reporting communicable diseases.

If You Need to Contact Us

You can reach our call center for customer care at 414-600-1020, or you can email us at Support@NOAHClinicalLaboratory.com

Frequently Asked Questions

What kind of COVID-19 test does NOAH Clinical Laboratory provide?

We do a real-time RT-PCR test that detects the SARS-CoV-2 virus, which is  the cause of COVID-19.

 

How accurate is your test?

Studies to validate this test demonstrated an acceptable alignment of positive and negative results from another FDA-approved COVID-19 test with emergency use authorization. There was no cross-reaction via in silico analysis performed on a respiratory pathogen panel. The test we use reliably detected SARS-CoV-2 at a level of 0.8 genomic copies per microliter.

 

Why is filling in the order form information so important?

We need accurate and precise information to identify the specimens correctly and make sure that they are in the condition needed for accurate testing; these are our criteria for accepting a specimen:

Elements of Patient Identification

  • Patient’s legal first name
  • Patient’s legal last name
  • Patient’s birth date

 

Specimens are only accepted if they display all of the above identifiers clearly marked both on the collection device and on the order documentation provided in the electronic interface.

 

Elements of Collection

  • Specimen collection date
  • Specimen collection time of day

When these are not provided, we will use a default collection time of 12:00AM on the collection date for determining stability.

 

Elements of Specimen Transport

  • All specimens must be at room temperature they arrive at our lab.
  • All specimens must be at our lab inside of 48 hours from their time of collection.
  • Collection tubes need to be free of obvious contamination and intact with no leakage.

 

How should samples be stored and shipped?

Samples must be sent at room temperature in a biohazard bag, with an absorbent pad (one sample per bag). Ship as soon as possible, ideally the day of collection. If a sample is more than 96 hours old, it will be refused.

 

Where should samples be delivered?

Send specimens to:

NOAH Clinical Laboratory
10501 W. Greenfield Ave.
West Allis, WI 53214

 

For hand delivery, contact us at Support@NOAHClinicalLaboratory.com or call 414-600-1020 for instructions.

 

How can I order a COVID-19 test from NOAH Clinical Laboratory?

Health care providers and organizations in Wisconsin may visit the State’s website to arrange ordering of testing supplies. (https://covid19supplies.wi.gov/Testing)

Healthcare providers outside of Wisconsin should contact NOAH Clinical Laboratory Customer Support at 414-600-1020.

 

What are the necessary ICD-10 codes, CPT codes, and LOINC codes?

Providers should use diagnostic codes that best describe why the test is needed. The provider who orders the test is responsible for the patient’s diagnosis. You will find common COVID-19-related diagnostic codes in our COVID-19 Customer Support Guide and on the requisition form for orders.

  • CPT Code: U0003
  • LOINC codes: 94500-6: (qualitative detection of N gene of SARS-CoV-2)

 

How long will it take to obtain results from NOAH Clinical Laboratory?

You can expect a 48 hour turn around time from when we receive the specimen in the lab, until we supply the provider who ordered the test with a result. You will have to add your collection and shipping time to our lab processing time to know how long it will take to get results.

 

Why do your swabs look different from one shipment to the next? Does this reflect a difference in how to use them or in how they perform?

Although our swabs may look different from time to time they always comply with the recommendations of the FDA and CDC for COVID-19 tests. All of the swabs that we supply are appropriate for collecting samples according to the instructions that come with the swabs.

 

How do I interpret the results of the COVID-19 test?

Positive: The test detected SARS-CoV-2 RNA (COVID-19)

Negative: The test did not detect SARS-CoV-2 RNA. Please note that not finding evidence of COVID-19 RNA on the test does not rule out COVID-19. The test should not be used as the only basis for making treatment decisions.

Inconclusive: This means we were not able to produce a result, due to the assay not working as expected, or that there was insufficient material in the specimen. In this case, recollection should be done.

 

References

Guidelines for Collecting

CDC. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
FDA. FAQs on Diagnostic Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2