1 Old Golf Course Rd, Monterey, CA 93940
All testing administered by our testing partners, COVID Clinic
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Rapid COVID-19 IgG/IgM Antibody Test
Results are generally reported within 60 minutes at most locations.
Assure COVID-19 IgG/IgM Rapid Test Device
- IgG: This is the most common antibody. It’s in blood and other body fluids, and protects against bacterial and viral infections. IgG can take time to form after an infection or immunization.
- IgM: Found mainly in blood and lymph fluid, this is the first antibody the body makes when it fights a new infection.
The Assure COVID-19 IgG/IgM Rapid Test Device, a test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 (often referred to as COVID-19 or the novel coronavirus) in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.
The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
September 23, 2020 and the FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on March 16, 2020 (updated May 11, 2020). The
- FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers during the public health emergency. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform waived, moderate or high complexity test;
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The sensitivity of the EcoTest COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- 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.
Standard Molecular NAAT (PCR or TMA) COVID-19 Test
Results are generally reported within 2 – 5 days
Covid Clinic utilizes multiple independent laboratories to process specimens collected and multiple molecular tests in order to offer PCR or TMA testing on a consistent basis. The molecular NAAT PCR or TMA test will be one of the following three tests, but Covid Clinic is unable to guarantee which of the tests will be utilized for a specific sample:
Roche cobas SARS-CoV-2 RT-PCR
Hologic Aptima SARS-CoV-2 Assay
LabCorp COVID-19 RT PCR Test
Covid Clinic is happy to offer COVID-19 PCR or TMA testing services. This testing meets the requirements for most travel restrictions; however, it is the purchaser’s responsibility to review any applicable travel restrictions prior to booking an appointment in order to ensure the service will meet the patient’s travel restriction requirement(s).
The specimen is collected by a nasal (anterior nares) swab. Please note that most travel restrictions require that a traveler’s test specimen IS COLLECTED within 48 to 72 hours upon arrival at destination. Results for the Standard Molecular NAAT (PCR or TMA) COVID-19 Test are generally reported within two to four days, but this delivery time is not guaranteed. If a patient needs their result delivered with a guaranteed turnaround time please see Covid Clinic’s Expedited Molecular NAAT (PCR or TMA) COVID-19 Test service offering.
Testing specimens collected at Covid Clinic are sent to third-party laboratories for processing. These laboratories may bill the patient’s insurance for their services. Covid Clinic strongly encourages all patients to provide any insurance information so patients may be able to avoid being billed directly by the third-party laboratory that processes the patient’s specimen. If a patient is uninsured, the third-party lab processing the specimen may attempt to collect public funding in lieu of billing the patient.
Rapid COVID-19 Antigen Test
Results are generally reported within 60 minutes
Quidel Corporation Sofia SARS Antigen FIA Test
Covid Clinic is offering the Quidel Corporation Sofia SARS Antigen FIA Test. This test has received an emergency use authorization from the FDA.
The specimen is collected by a nasal swab. The cotton swab does not need to be inserted far into the nose, and is rotated in a circle around the entire inside edge of each nostril at least three times. Results are generally available within 24 hours and delivered to the patient via email (with the individual’s consent).
Rapid RT-PCR COVID-19 Test
Results are generally reported within 24 hours
Satisfies most travel restriction requirements
Collected by anterior nares nasal swab (front of the nose only)
The Rapid RT-PCR COVID-19 Test is a molecular, in vitro diagnostic test utilizing end point reverse transcriptase polymerase chain reaction (RT-PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The four steps utilized to perform the test are lysis of the virus, reverse transcription of viral RNA to cDNA, nucleic acid amplification, and detection.
The Rapid RT-PCR COVID-19 Test has been released under FDA Emergency Use Authorization (EUA) for the detection of nucleic acid from SARS-CoV-2 (the virus responsible for COVID-19 infection), and can be used in applications that require molecular/ RT-PCR testing. Please consult your state health department for additional information regarding specific uses (such as pre and post travel requirements). Many travel restrictions require a RT-PRC, molecular, or NAAT test be conducted prior to arrival at the destination. The Rapid RT-PCR COVID-19 test satisfies most travel requirements; however, it is the purchaser’s responsibility to verify the test will be accepted for travel prior to purchase.
Testing for Businesses, Organizations, and Events
Lifeline Health and testing facilitator COVID-Clinic are happy to offer COVID-19 related testing services to any business, organization, or event. To inquire, please email email@example.com with the dates you would like to begin testing, the estimated number of people to be tested, and the frequency of testing. Please include the business’s name, the primary contact’s phone number, and email address in the email subject line.