COVID-19 Testing
COVID-19 PCR Testing at Pangea
Laboratory
The federal COVID-19 public health emergency is set to end on May 11, 2023. As per California law, most insurance carriers will continue to cover COVID-19 testing. It’s important to note that while we are a participating provider of Medi-Cal and Medicare, we are considered out-of-network for commercial payers. Consequently, we recommend patients verify any potential changes to their policies with their insurance carriers before undergoing testing, as coverage and cost-sharing for COVID-19 testing may now differ based on the insurance plan.
COVID-19 PCR Testing at Pangea Laboratory
EUA PCR
Test
24 Hour
Turnaround
Accurate
Detection
Throat Swab
Pangea Laboratory is a CLIA-certified and CAP-accredited medical testing laboratory that specializes in the high complexity testing required to run accurate and timely COVID-19 diagnostics. We offer a rapid 24-hour turnaround time from the receipt of samples at our Southern California-based laboratory, to delivering certified COVID-19 test results. Pangea Laboratory has a strong track record of providing reliable COVID-19 PCR testing across Los Angeles and Orange County, including at pop-up testing locations at OC Great Park, OC Fairgrounds, and Port of Los Angeles.
Our Testing Partners
Pangea Laboratory is proud to partner with leading telehealth companies and community health organizations to keep COVID-19 testing easily accessible across Tustin, Irvine, Newport Beach, and other communities in Orange County and Los Angeles. To find a drive-thru testing location near you in Southern California, or to order an at-home PCR test kit, visit one of our partner sites today:
No-Cost COVID Testing for the Uninsured
In early 2022, Pangea Laboratory donated $5 million worth of PCR tests, so the uninsured in Los Angeles and Orange County could still have access to free COVID-19 testing. We are currently working with non-profits including CORE Response Los Angeles and community health organizations like Latino Health Access to continue offering COVID-19 PCR testing at no cost to those without health insurance. To schedule a free COVID-19 PCR test, contact these organizations today:
Pangea Laboratory’s PCR Test Kit: Quick SARS-CoV-2 rRT-PCR Test Kit
Our COVID-19 diagnostic workflow utilizes Zymo Research’s Quick SARS-CoV-2 rRT-PCR Test Kit. It can be used to test nasal, mid-turbinate, nasopharyngeal, or oropharyngeal swabs, sputum, tracheal aspirates, and bronchoalveolar lavage.
The United States Food and Drug Administration (FDA) has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
Healthcare providers and patients can view the following fact sheets for more information on this test:
The Quick SARS-CoV-2 rRT-PCR Kit is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Of the approved COVID-19 tests, the FDA’s SARS-CoV 2 Reference Panel has ranked this among the most sensitive PCR tests available, able to accurately detect a Product LoD of 450 NDU/mL or less.
The Quick SARS-CoV-2 rRT-PCR Test consists of the following materials that perform to CLIA and CAP guidelines:
- Swab Collection Device – Used to collect nasal and throat specimens
- DNA/RNA Shield Reagent – Reagent that maintains specimens at room temperature (Approved for up to 56 hours) and avoids the need for cold-chain shipping and handling
To use this diagnostics kit for COVID-19 testing, it must be ordered for a patient by their healthcare provider. We partner with national leaders in telehealth to provide reliable COVID-19 testing solutions to businesses, schools, and organizations around the US, including drive-up testing, on-site pop-up testing, concierge-style service, and at-home test kits.
Contact Us Today to Learn More About Our Testing Options
COVID-19 PCR Testing Benefits
Polymerase chain reaction (PCR) is a reliable and commonly used chemical process that quickly and exponentially amplifies target nucleic acid, producing large quantities of copies of a specific segment of DNA or RNA to create a large enough volume for sequencing and analysis.
Within the context of COVID-19 testing, PCR tests can detect the genetic material from the SARS-CoV-2 virus that causes COVID-19. Since the start of the pandemic, PCR tests have been the gold standard for detecting the presence of an active COVID-19 infection at the time of testing. Laboratory PCR testing remains more accurate than rapid antigen tests and enables appropriate isolation and treatment.
The Quick SARS-COV-2 rRT-PCR Test has been able to accurately detect all COVID-19 variants identified thus far:
| - Alpha (B.1.1.7 and Q lineages) | - Beta (B.1.351 and descendent lineages) |
| - Gamma (P.1 and descendent lineages) | - Epsilon (B.1.427 and B.1.429) |
| - Eta (B.1.525) | - Iota (B.1.526) |
| - Kappa (B.1.617.1) | - 1.617. |
| - Mu (B.1.621, B.1.621.1) | - Zeta (P.2) |
| - Delta (B.1.617.2 and AY lineages) | - Omicron (BA.1 and BA.2 lineages) |
COVID-19 PCR Testing Sample Collection
Please note that Pangea Laboratory does not collect specimens for this test on-site at our laboratory. Each sample we process will need to be collected by a physician or healthcare provider or collected under the supervision of a healthcare provider (For instance, as part of a telehealth consultation).
For patients self-collecting samples at home, an appropriate specimen should be collected using the provided swab kit, under the guidance of a healthcare provider. The specimen should then be sent to Pangea Laboratory as instructed. Alternatively, patients can make an appointment at any one of our conveniently located testing sites to have a sample collected.
Under federal regulations, a “healthcare provider” is defined as a doctor of medicine or osteopathy, podiatrist, dentist, chiropractor, clinical psychologist, optometrist, nurse practitioner, nurse-midwife, or a clinical social worker who is authorized to practice by the State and performing within the scope of their practice as defined by State law, or a Christian Science practitioner. A health care provider also is any provider from whom the University or the employee’s group health plan will accept medical certification to substantiate a claim for benefits.
COVID-19 PCR Testing Sample Collection Instructions
The sample collection kit is easy to use:
Step 1
Open the sterile swab
Step 2
Swab the back of the mouth, close to the tonsils, five times
Step 3
Open the collection tube
Step 4
Insert the swab into the tube, ensuring that the flocked end is coated in the reagent, and break off the excess handle at the notch
Step 5
Seal the collection tube tightly
Now your sample is ready for shipping to our laboratory.
COVID-19 PCR Testing Kit Shipping and Collection
Please contact our team directly to schedule the delivery of our collection devices. Samples are to be shipped back to our laboratory or dropped off at designated collection drop boxes.
| 24602 Aliso Creek Rd, Laguna Niguel, CA 92677 | 1450 E La Palma Ave, Anaheim, California 92805 |
| 2701 Fairview Rd, Costa Mesa, CA 92626 | 450 W 4th St, Santa Ana, CA 92701 |
| 2100 E 4th Street, Santa Ana CA 92705 | 7150 La Palma Ave, Buena Park, CA 90620 |
| 1 Journey, Aliso Viejo, CA 92656 | 30341 Crown Valley Pkwy, Laguna Niguel, CA 92677 |
| 23721 Moulton Pkwy, Laguna Hills, CA 92653 |
24602 Aliso Creek Rd, Laguna Niguel, CA 92677
1450 E La Palma Ave, Anaheim, California 92805
2701 Fairview Rd, Costa Mesa, CA 92626
450 W 4th St, Santa Ana, CA 92701
2100 E 4th Street, Santa Ana CA 92705
7150 La Palma Ave, Buena Park, CA 90620
1 Journey, Aliso Viejo, CA 92656
30341 Crown Valley Pkwy, Laguna Niguel, CA 92677
23721 Moulton Pkwy, Laguna Hills, CA 92653
COVID-19 Laboratory PCR Testing Workflow
Step 1 Specimen Collection
Nasal or throat specimens are collected on a swab by a healthcare provider, or under the guided supervision of a healthcare provider. The swab is then sealed in a tube containing DNA/RNA Shield, which is a reagent that preserves the DNA/RNA material at room temperature, to allow for more accurate test results. The sample is sent to our laboratory in Southern California.
Step 2 Extraction
Once a sample is received at our laboratory, it goes into a quality-controlled process where genetic material (RNA) is extracted from the sample with an RNA Extraction Kit, according to the manufacturer’s information for use. At this stage, our laboratory scientists will be able to assess the quality of the sample submitted. In case of incorrect specimen collection, we will notify your healthcare provider for a recollection.
Step 3 PCR
The extracted material then goes through an amplification process that will increase the amount of the targeted genetic material, until there is sufficient volume to accurately test for the presence of SARS-CoV-2. Our testing software will be able to interpret the signals as either a positive or negative result.
Interpreting the Results of a COVID-19 Laboratory PCR Test
What does it mean if I have a positive test result?
A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC guidelines to reduce the potential transmission of disease.
The Quick SARS-CoV-2 rRT-PCR Kit has been designed to minimize the likelihood of false positive test results. However, it is still possible that this test can give a false positive result, even when used in locations where the prevalence is below 5%. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of treatment or therapy, or other unintended adverse effects.
What does it mean if I have a negative test result?
A negative test result for this test means that SARSCoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. It is possible to test a person too early or too late during COVID-19 infection to make an accurate diagnosis via Quick SARS-CoV-2 rRT-PCR Kit.
When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illnesses) are negative.
If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing with an alternative method should be considered by healthcare providers in consultation with public health authorities. Additional testing may be helpful to ensure testing was not conducted too early. Risks to a patient of a false negative test result include delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in an increased risk of spread of COVID-19 within the community, or other unintended adverse events.