Start by reviewing our Testing Guide:
How to Get Tested:
Option 1
I have no symptoms and need a PCR (RNA throat/nasal swab) test for travel, surgery, or work.

Please download and complete our requisition form and bring it to your appointment.

Then schedule your appointment online:

Note: Please schedule your testing for travel or surgery 72 hours before you need the result.

Please note, a physician's orders for pre-surgery or work-place testing are required.

Option 2
I am currently experiencing one or more of the COVID symptoms listed below and need a PCR (RNA throat/nasal swab test) or a blood antibody test.

Obtain a physician order for the test. (Please bring it with you or have it faxed to our lab at (208) 472-1078)

Please download and complete our requisition form and bring it to your appointment.

Then schedule your appointment online:

Symptoms:

Fever above 100.4 degrees

Cough

Shortness of breath

Lost of taste or smell

Diarrhea

Nausea or vomiting

Loss of appetite

Fatigue

Headache

Chills

Muscle pain

Option 3
I need a physician referral for testing.

At this time, ACT Idaho can order serum antibody tests for you. If you believe you need a PCR swab test, please obtain a referral from your primary care provider and follow option 2 above.

For antibody tests, schedule through ACT Idaho:

Information 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.

Fact Sheets for Patients:
Quidel Direct PCR (Swab) Test:
Abbott IgG Antibody Test (Serum):
Lateral Flow IgG-IgM Antibody Test (Serum):

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 main office in Garden City. 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.

Download this useful guide for more information about our lateral flow antibody test:
Information for Providers:

We currently offer three tests--Molecular PCR (Swab), Abbott IgG Antibody Test (Serum), and Lateral Flow IgG-IgM antibody test (Serum). For additional reference, please download the fact sheet for each test below.

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

Fact Sheets for Providers:
Quidel Direct PCR (Swab) Test:
Abbott IgG Antibody Test (Serum):
Lateral Flow IgG-IgM Antibody Test (Serum):
Rapid IgM-IgG Combined Antibody test for Coronavirus

Cole Diagnostics is offering a Rapid IgM-IgG Combined Antibody test for Coronavirus. There are many manufacturers offering the test in the United States. We are reviewing different testing as it becomes available and will adopt the most optimal platform. The test kit we currently use has been validated and is in the process of working through the Emergency Use Authorization process through the FDA. The FDA guidelines that were published on March 16, 2020 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 contact with other positively tested COVID-19 patients 7-10 days prior to testing, those who have symptoms of COVID-19 such as  a fever of 100.4°F or greater, upper respiratory symptoms such as a cough, sore throat, shortness of breath, or difficulty breathing (even if these symptoms are relatively mild), or those who have had these symptoms within the past 2 months.

 

What is the test?

The 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 10 minutes after the buffer and sample are combined in the cassette sample well. Results will be reported within 24 hours of specimen receipt in our lab.

 

How accurate are the results?

Validation studies for lateral flow immunoassays show a sensitivity of about 92% and specificity of 98%, based on large cohort studies. The positive predictive value is partially dependent on the overall prevalence in the community, which is currently undetermined. 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, the timing of the test, problems in the way the test is collected, and potential cross reactivity. In our own lab, we have confirmed the test with samples from symptomatic patients that 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. It is very likely that the patient does not have antibodies to the SARS-CoV-2 virus at this time. Studies show that it can take 7-10 days from initial exposure to onset of symptoms. Antibodies begin to develop within 5-7 days of symptoms. It is possible that it is too early to tell if the patient has antibodies to the virus. If the test is negative, but symptoms such as a fever, cough, or shortness of breath are present, consider follow up testing by PCR or testing for other illnesses such as influenza. Repeat antibody testing in 7-10 days may be helpful if the patient has been exposed or had symptoms of COVID-19.


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. The IgM antibody typically appears within 5-7 days of symptom onset and persists until approximately day 14. According to global data, up to 50% of patients may be asymptomatic with a positive IgM result. The patient should be isolated, and any close contacts should be followed for symptoms and should be tested. In some less common cases, the IgM antibody test is positive due to a cross reaction with another antibody or protein such as rheumatoid factor. A follow-up test in 7-10 days is recommended.

 
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. IgG antibodies typically begin to appear at about day 14 post symptoms. If the patient has only IgG antibodies, and is at least 7 days post symptoms, they are most likely not contagious. At this time, it is unknown how long IgG immunity lasts for this virus. Rarely, it is also possible to have a positive IgG result due to another past infection with a similar virus.


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 patient is still in the acute phase of infection and may be symptomatic, and is most likely still contagious. In addition, the IgG immune response is beginning to ramp up. Repeat antibody testing in 7-10 days is recommended to follow conversion to IgG only.

 

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 to perform the test. Results will be reported within 24 hours of receipt of the test.

 

How does this compare to PCR screening?

PCR testing is considered the gold standard for testing. The PCR test detects the presence of the virus in the nasal passages. The challenges of PCR testing include the availability of equipment, reagents, and trained testing personnel.  PCR testing is also prone to false negative tests, particularly outside of the 5-10 day window when symptoms are most acute, and is less reliable when the patient is not exhibiting upper respiratory symptoms.

 

Is reflex testing necessary?

If the test is positive, the patient should be treated and quarantined based on symptoms and should be considered contagious. If the patient is within 5 days of symptom onset, a diagnostic PCR test may be informative. Repeat antibody testing at 7-10 day intervals will confirm the presence of antibodies, and follow the progression of the antibodies to IgG only. Close contacts of the patient should also be traced and tested.

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.

 

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. 

Cole Diagnostics

CLIA ID: 13D251000

7988 W. Marigold St. Ste 150

Garden City, ID 83714

© 2018 Cole Diagnostics

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Tel : (208) 472-1082

Fax : (208) 472-1078