Cole Diagnostics

CLIA ID: 13D251000

7988 W. Marigold St. Ste 150

Garden City, ID 83714

© 2018 Cole Diagnostics

Follow Us:

Tel : (208) 472-1082

Fax : (208) 472-1078

How to Get Tested:
1.
Get a Referral

Obtain a lab order from your primary care provider or a client office of Cole Diagnostics

2.
Download the Form

Bring this form, completed, with a signature by your provider to our Meridian Patient Service Center (by appointment only)

3.
Call to Schedule Your Draw

Testing currently available by appointment between 8 AM and 4 PM, Mon-Thur and 9 AM - 1 PM Saturday

Cole Main Office: (208) 472-1082

For Patients:

Testing is available, but you must be screened your primary care provider. We are encouraging telemedicine visits to promote everyone's safety. Once your doctor has reviewed your medical specifics and wants to do testing, you can download our form and schedule your draw. The form needs to be completed entirely. Please be directly on time to your appointment--we will be very busy with draws and need to work right on schedule.

Download this useful guide for more information about our test:
For Providers:

We are accepting tests from any provider who can legally order laboratory tests in the state of Idaho. Please either draw a lavender tube (refrigerated and stable for 5 days) and contact our office for a pickup, bring us the sample, or send your patient to our Meridian Patient Service Center. Your patients need to complete our Requisition Form and schedule their draw with us. We're doing everything we can to screen as many patients as possible.

Please contact our office with any additional questions you may have.

Rapid IgM-IgG Combined Antibody test for Coronavirus

The test has been developed by BioMedomics, based in North Carolina. The test has been validated and the company is in the process of working through the Emergency Use Authorization with the FDA. The FDA published guidelines on March 16, 2020 that provide for the use of commercial serologic testing.

Who should be tested?

The test should be performed on patients who meet criteria for COVID-19 screening. The test is less informative for patients in the very early stages (within 5 days) of exposure. Candidates for testing include patients who have had exposure to other positively tested COVID-19 patients, those who are running a fever of 100.4°F or greater, or those have upper respiratory symptoms such as a cough, sore throat, shortness of breath, or difficulty breathing, even if these symptoms are relatively mild.

 

What is the test?

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies against the novel coronavirus in human serum, plasma or whole blood in vitro. This type of testing is widely used for diagnosing a variety of infections.

 

How soon are results available?

Results are valid 15 minutes after the buffer and sample are combined in the cassette sample well. 

How accurate are the results?

Data from testing on a large cohort of over 500 patients in China found this test to have a specificity of 88.66% and a sensitivity of 90.63%. This means that approximately 90% of patient who test positive do, in fact, have the disease, and that about 90% of patients who test negative do not have the disease. As with any medical test, some false positive results and some false negative results are expected due to limitations in testing methods such as the antibody load of the patient, and problems in the way the test is collected. Based on data coming from testing of patients in Asia, approximately 95% of patients tested (using all testing methods) will not have the disease.

In our own lab, we have confirmed the test with sample from a symptomatic patient that previously tested positive for SARS-CoV-2 with a PCR test.

 

What do the results tell me?

A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
1 | Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
2 | Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
3 | Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
4 | Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.

The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of this test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

How is the test performed?

A venous blood sample will be collected in a lavender top EDTA tube. The blood will be sent to the main Cole Diagnostics lab, where it will be spun down to separate the plasma. 10uL of plasma will be used for performed the test. Results will be reported within 24 hours of receipt of the test. A verbal report of positive results will be communicated to the provider as soon as possible.

 

How does this compare to PCR screening?

PCR testing is considered the gold standard for testing. The challenges of PCR testing include the availability of equipment, reagents, and trained testing personnel.  In addition, accurate PCR testing requires cold chain transport. Because of these constraints, PCR testing currently is taking up to 10 days for results to be available.  PCR testing is also prone to false negative tests, and is less reliable when the patient is not exhibiting upper respiratory symptoms.

 

Is reflex testing necessary?

If the test is positive, no further testing is necessary. The patient should be treated and quarantined based on symptoms and should be considered contagious.

If the patient tests negative for both antibodies, but has significant upper respiratory symptoms, follow up testing may be warranted. This could include PCR testing for COVID-19 and/or testing for Influenza.

 

Per the FDA and the BioMedomics website:

While the FDA EUA application is under review, please note the following information:

  • This test has not been reviewed by FDA

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. 

This information as well as additional information and resources can be found at www.biomedomics.com