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NOAH Laboratory is providing Serology (antibody) and Molecular Testing (RT-PCR) for COVID-9. Learn More

Testing for Covid-19

At Noah Clinical Laboratory we not only continue to devote ourselves to toxicology testing but have joined in the fight against the new coronavirus, Covid-19, as well. 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. It is available through accredited providers of healthcare including US-based physicians. The test is meant for those individuals meeting the updated guidance of the CDC for diagnosing and treating infections with Covid-19.

Our staff at Noah Clinical Laboratory are utilizing the skills we have acquired from state of the art toxicology testing to join in the effort to contain this crisis in public health and end the risk of this disease to society. If you need more information about the Covid-19 test that Noah Clinical Laboratory provides, you can contact our support staff at 414-255-2798.

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 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 authorized under an emergency use authorization by the FDA. This emergency use is limited to authorized laboratories such as our own.

The Covid-19 test is authorized for detecting SARS-CoV-2 nucleic acid only and not for detecting any other pathogens, viral or bacterial. And, the test we use is OK’d under an emergency authorization that 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 via Noah Clinical Laboratory to providers of healthcare who have set up an account with us. Individuals wanting tests for Covid-19 should check with their own healthcare providers or follow advice of 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 ask for supplies for testing. The site is as follows.

https://covid19supplies.wi.gov/Testing

You can find more information about the test we do at the COVID-19 Customer Guide Outline in the section for Additional Resources.

Non-Wisconsin healthcare providers can contact Noah Clinical Laboratory customer services at 414-600-1020 and get help there.

The Process for Testing

Read this section for a summary of the testing process.

Collecting a Sample

You can collect a sample using any of the CDC or FDA-recommended methods. These are:

  • 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 these types:

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

You can find FDA answers to frequently asked questions (FAQ) about Diagnostic Testing for SARS-CoV-2 at this 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 June 24, 2020.

Collection Supplies

If you need supplies to collect and transport Covid-19 testing samples our lab will be pleased to provide what you need. These include a plastic shaft, synthetic-tipped swab as well as RNAse-free transport media (normal saline). Our supplies are meant for anterior nasal sample collection. We include exact instructions with our supplies. Watch the following video to see the process of sample collection and handling in action.

Handling Specimens and Shipping to Noah Clinical Laboratory

There are a number of important and necessary steps to follow to get the best results from your testing. First of all specimens need to be properly labeled with exact patient information so that our reporting can be done correctly. In addition, collection info 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. These are our requirements:

Criteria for Accepting Specimens

Necessary patient information for patient identification

  • First Name
  • Last Name
  • Birthdate

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

Elements of collection

  • Specimen Collection Date
  • Specimen Collection Time

If you not provide a time or collection we will assume 12:00 AM on the date specified for determining stability.

Elements of Specimen Transport

Specimens must arrive at our lab chilled using cold packs, ice packs or refrigeration in the two to eight degrees Celsius range.

And, besides arriving chilled, they must arrive at our lab with seventy-two hours of when they were collected.

For samples that arrive after the seventy-two-hour cutoff, we will only accept them if they have been frozen to minus seventy degrees Celsius right after collection and sent with sufficient dry ice which is substantially coder than a commercial or home freezer.

And, 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 Info@NOAHClinicalLaboratory.com or call 414-600-1020 for instructions.

Delivery of Results

We provide test results for Covid-19 testing to the provider who ordered the test via secure electronic communication. If you organization has IT ability and staff contact our IT team to set up a results delivery option.

Unless you set up another option, every provider who orders a Covid-19 test will be called directly when there are positive test results. In addition, all results are reported to the appropriate state health department following their requirements for reporting communicable diseases.

Patients will be able to see their results via our electronic portal after the health care provider has been notified.

If You Need to Contact Us

You can reach our call center for customer care at 414-600-1020. Follow the voice prompts to get the Covid-19 testing.

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-1 virus which is the cause of Covid-19.

How accurate is your test?

Studies to validate this test demonstrated a hundred percent match for both negative and positive results from another FDA-approve Covid-19 test with emergency use authorization. There was no cross-reaction with the test was performed on a respiratory pathogen panel. The test we use reliably detected SARS-CoV-2 at a level of 1.2 genomic copies per microliter. While these were lab-based results, correlation is the clinical condition when patients have Covid-19 has not been proven.

Reference

Need their reference link

FDA. Emergency Use Authorization SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratory). https://www.fda.gov/media/138328/download. Accessed August 6, 2020.

What kinds of specimens are accepted?

The supplies that Noah Clinical Laboratory provides are appropriate for anterior nasal specimens. Nevertheless, we accept all specimens whose collection followed CDC and FDA recommendations. These specimens need not be collected with supplies from our lab.

Reference

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.

Accessed June 24, 2020.

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. Accessed June 24, 2020.

Why is filling in the order form information so important?

We need accurate and precise information in order to identify 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 first name
  • Patient’s last name
  • Patient’s birth date

We will only accept specimens that have each of these pieces of identification clearly marked either on the collection device or tube or 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 12:00 on the collection date for determining stability.

Elements of Specimen Transport

  • All specimens must be chilled when they arrive at our lab. This can be done with refrigeration at two to eight degrees Celsius, ice packs, or cold pack.
  • All specimens must be at our lab inside of seventy-two hours from their time of collection.
  • If a specimen arrives more than 72 hours after collection, we will accept it only if it was frozen to minus 72 degrees immediately after it was collected and shipped packed with dry ice.
  • Collection tubes need to be free of obvious contamination and intact with no leakage.

How should samples be stored and shipped?

Using ice packs, a cooler, or a refrigerator, chill all samples to between two and eight degrees Celsius. Ship as soon as possible, ideally the day of collection. If a sample is more than seventy-two hours old it will be refused unless it has been chilled to minus seventy degrees Celsius or lower. Send these with lots of day ice!

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 Info@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) More information about our Covid-19 test is available in Additional Resources, Covid-19

Healthcare providers from 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?

You will find the common Covid-19-related diagnostic codes in our Covid-19 Customer Support Guide and on the requisition form for orders. However, none of this is meant to replace the ordering provider’s medical judgement. 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.

  • CPT Code: U0003
  • LOINC codes: 94533-7: (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 seventy-two hour delay from when we receive the specimen until we provide the provider who ordered the test with a result. You will have to add the time it takes to collect and ship the specimen to our 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 nasal 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.

Invalid: 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 if clinical conditions indicate.

How much does the test cost?

Our price for the test is $209.