COVID 19 Testing

Asymptomatic Testing

Immune Response Antibody Test IgG and IgM - Blood 

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Use for: Screening for the return to work, school, and activity faster

Get this blood test if you:

Had or suspect you had COVID-19 but have not experienced any symptoms in at least 10 days.  Symptoms include: fever, cough, shortness of breath, sore throat, feeling weak.  

This test detects antibodies which show if you have already been exposed to and produced an immune response to COVID-19.   An antibody may not be able to show if you have a current infection and may take 1-3 weeks after infection to make antibodies. Previous exposure means you may now have some level of immunity to the virus.  Understanding your immune response gives you and your doctor or healthcare provider the information to assist in making an informed decision about returning to work or activity.  

Who can get tested 

Immune response testing is available only to patients who are not currently experiencing COVID-19 symptoms and have not experienced symptoms within 10 days.

How to test

A healthcare provider will submit an order for you to get a COVID-19 immune response test.  A phlebotomist will draw your blood and the specimen is sent to Bach Diagnostics for testing.

Turn around time

Results will be available online within 24-28 hours after arriving at the laboratory.

Where to get tested

Call the lab to make an appointment at one of our many draw stations.  Or call us to schedule our mobile phlebotomy service for large groups.  1 (800) 544-4181

Symptomatic Testing

Active Infection RNA Test

Molecular PCR Testing - Nasal Swab, Oral Swab or Sputum

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Use for: Dectection and confirmation of active infection.

Get this swab test if you:

Currently have symptoms of COVID-19 or were exposed to COVID-19 within the last 14 days.  Symptoms include:  fever, cough, shortness of breath, sore throat,  and feeling weak.   

This test helps diagnose whether you currently have an active COVID-19 infection.   A diagnosis can guide you and your doctor to make an informed decision about self-quarantining to protect your family and friends.

 

 

Who can get tested

Active infection testing is for patients who are currently experiencing COVID-19 symptoms or were exposed to the virus in the last 14 days.  Common COVID-19 symptoms include fever, cough, and shortness of breath.

How to test

Your healthcare provider will collect a specimen through a nasal swab, throat swab, or sputum sample.   The specimen is sent to Bach Diagnostics for testing.  

Turn around time

Results will be available online within 24-28 hours after arriving at the laboratory.

Where to get tested

Call the lab to make an appointment at one of our many draw stations.  Or call us to schedule our mobile phlebotomy service for large groups.  1 (800) 544-4181

Which Test is Right For Your Patients?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                                                                     www.IDSA.com

Results Interpretation 

Test Results 

PCR    IgM     IgG                  Clinical Significance:

            -           -                      Patient may be in the window period of infection

  +          +           -                      Patient may be in the early stage of infection

  +          +           +                    .Patient is in the active phase of infection

  +           -           +                     Patient may be in the late or recurrent stage of infection

  -           +           -                      Patient may be in the early stage of infection. PCR may be a false negative

  -            -           +                     Patient may have had a past infection, and has recovered

  -           +           +                     Patient may be in the recovery stage of an infection, or the PCR may be a false negative

Detection Limits

Detection Method                                          Limit of Detection

PCR testing - SARS-CoV-2 RNA                             1  to 28 days post infection

IgM testing - Antibody Testing for IgM                   7  to 21 days

IgG testing - Antibody Testing for IgG                  14 to years - Long term immunity 

 

                                                        

                                                           Infection Timeline

 

 

                                               Figure 1: This infection timeline is based on the current knowledge about the rise and fall

                                               of COVID-19 RNA (SARS-CoV-2), IgM antibody and IgG antibody and the correlation of

                                               these levels vary with the initial time of infection, onset of symptoms, and recovery phase.

                                               Detection limits are based on average times for viral replication and average times for

                                               IgG and IgM production. Detection limits may be different based on biological and viral

                                               variations.

Sensitivity and Specificity of Assay

Sensitivity of 91.2% to 95.6%

Using RT-qPCR-confirmed SARS-CoV-2 positive specimens, the clinical sensitivity of the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test was estimated at 91.2%. When used in combination with the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test, clinical sensitivity was found to be 95.6%.

Specificity of 96%

 

Using confirmed SARS-CoV-2 negative specimens, the clinical specificity of the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test was estimated at 97.3%. When used in combination with the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test, clinical specificity was found to be 96.0%.

 

Using confirmed SARS-CoV-2 negative specimens, the clinical specificity of the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test was estimated at 97.5%. When used in combination with the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test, clinical specificity was found to be 96.5%.

 

Symptoms 

People with COVID-19 have a wide range of reported symptoms, ranging from mild to severe illness.  Symptoms may appear 2-14 days after exposure to the virus.  

Common Symptoms:

  • Cough

  • Shortness of breath or difficulty breathing

  • Fever

  • Chills

  • Muscle pain

  • Sore throat

  • New loss of taste or smell

Less common symptoms may include:

  • Nausea

  • Vomiting 

  • Diarrhea

When To Seek Medical Attention

Emergency warning signs for COVID-19.  Please seek emergency medical care immediately if you have any of these symptoms:

  • Trouble breathing

  • Persistent pain or pressure in the chest

  • New confusion

  • Inability to wake or stay awake

  • Blue-ish lips or face

This list is not all possible symptoms.   Please call your medical provider for any other symptoms that are severe or concerning to you.

Who Can Get Tested

Testing will be based on Federal and State guidelines.   California's guideline is categorized into two tiers:  

Tier 1

  • Hospitalized patients

  • Healthcare workers, first responders, and other social service employees

  • Any symptomatic person

  • People exposed to infected individuals in places where COVID-19 risk is high facilities including:

  • Asymptomatic residents or employees of group living 

    • After positive cases have been identified in a facility​

    • Before resident admission or re-admission to a facility

  • People in essential Jobs (Healthcare/Public Health, emergency services, food and agriculture, energy, water and wastewater, transportation and logistics, communications and information technology, government operation and other community-based essential function, critical manufacturing, financial services, chemical and hazardous material, defense industiral base, industrial, commercial, residential, and sheltering facility and services.   https://covid19.ca.gov/essential-workforce

​Tier 2

  • Low-risk, asymptomatic people

Bach Diagnostic’s COVID-19 PCR test has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

Bach Diagnostic's is providing serology testing based on IgG and IgM. Such tests have either received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) or were released for use under FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administration Staff” that was updated on May 4, 2020. Tests being performed under an EUA have not been FDA cleared or approved and LabCorp has completed independent validation of these tests. In addition, various manufacturers have submitted or will seek EUA for their tests

References:

1. Weaver, C. Questions About Accuracy of Coronavirus Tests Sow Worry. The Wall Street Journal. April 2nd, 2020. Retrieved from https://www.wsj.com/articles/questions-about-accuracy-of-coronavirus-tests-sow-worry-11585836001

2. Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J2. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV2). Science. 2020 Mar 16. pii: eabb3221.

3. Lauer, S. et al., 2020. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Annals of Internal Medicine.

4. National Health Commission of the People’s Republic of China, New Coronavirus Pneumonia Diagnosis and Treatment Program (Trial Version 7).

5. To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC et al. (2020). Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23. pii: S1473-3099(20)30196-1.

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