NKGen Biotech offers COVID-19 RT-PCR, SalivaDirect™and Antibody tests
Now offering COVID-19 RT-PCR testing from saliva samples with SalivaDirect™
NKGen Biotech offers a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay to detect viral RNA for COVID-19 diagnosis and to help limit the spread of infection. The test detects the presence of SARS-CoV-2, the virus responsible for COVID-19 disease, and is for patients who exhibit signs and symptoms of COVID-19 infection. This test requires an upper respiratory (swab) sample or a saliva sample (SalivaDirect™Test) collected under the supervision of a healthcare professional.
We also offer a COVID-19 Antibody Test (serology) which is an immunochromatographic assay that measures SARS-CoV-2 specific IgG/IgM antibodies from an immune response to COVID-19 infection. The test detects the presence of IgG and IgM antibodies to SARS-CoV-2 and is for patients who are not actively ill and have not experienced any symptoms for the past 10 days. This test requires a blood sample.
All the COVID-19 RT-PCR and Antibody Tests, performed at NKGen Biotech, are authorized by the FDA under Emergency Use Authorizations (EUA). See RT-PCR and Antibody Test Fact Sheets for patients and healthcare providers at the bottom of this webpage.
A COVID-19 test order by a physician is required. Patients should contact their primary care physician to obtain the test order before testing. If the patient does not have a physician, contact NKGen Biotech at 949-396-6830 for assistance.
The SARS-CoV-2 (COVID-19) molecular test (nucleic acid detection) can detect the presence of SARS-CoV-2 viral RNA in upper respiratory samples (nasal/oropharyngeal swab or saliva–SalivaDirect™). This test is used to aid in the diagnosing of active COVID-19 infections. Negative test results indicate that SARS-CoV-2 viral RNA was not detected in the respiratory sample while positive test results mean SARS-CoV-2 viral RNA was detected in the sample. A negative test does not necessarily rule out COVID-19 infection and results should be considered in the context of a patient’s recent exposure and the presence of clinical signs and symptoms consistent with COVID-19. For information on how to order and FAQ on SalivaDirect™, please click here.
A COVID-19 RT-PCR test order form must be completed by a healthcare provider/physician.
The form must accompany the respiratory swab sample when submitted to NKGen Biotech for processing or faxed to NKGen Biotech if referring patient to our facility for on-site collection.
Patient upper respiratory specimen samples can be collected by a healthcare provider or on-site at the NKGen Biotech facility.
To schedule an on-site swab collection at NKGen Biotech America in Santa Ana, CA contact NKGen Biotech at 949-396-6830.
If the upper respiratory swab sample is collected at NKGen Biotech, the sample will be prepared and processed on-site.
If the swab sample is collected at another healthcare providers site, the sample must be collected and prepared for shipment to NKGen Biotech as per sample prep procedures along with the test order.
What does the test measure?
The test detects the presence of SARS-CoV-2 RNA indicating that a person is infected and has COVID-19. A positive result indicates SARS-CoV-2 RNA has been detected in the upper respiratory tract sample submitted for testing. A negative result indicates that SARS-CoV-2 RNA was not detected in the respiratory sample.
What specimen is required?
This test requires an upper respiratory sample collected from individuals suspected of COVID-19 by healthcare providers (nasopharyngeal, oropharyngeal, nasal, or mid-turbinate swab collection).
What do the test results mean?
A positive result indicates that SARS-CoV-2 RNA was detected and therefore the patient is infected and presumed to be contagious.
A negative result indicates that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. A negative result does not rule out COVID-19 and should not be used as the only basis for excluding the possibility of COVID-19.
How to order?
If the physician is collecting the specimen, send specimen (collected as per specimen collection guidelines) along with the completed COVID-19 Test Order Form to NKGen Biotech for processing.
If the patient will be sent to the NKGen Biotech facility for specimen collection, the doctor must fax completed order form to 949-861-9565 (FAX) prior to the patient calling for an appointment. After the test order has been faxed, patients should call NKGen Biotech at 949-396-6830 to set up an on-site collection appointment. Payment will be collected over the phone at the time of scheduling.
If the patient does not have a doctor’s order, they can call NKGen Biotech at 949-396-6830 to schedule an appointment and request a test order from one of our partner physicians by filling out a screening questionnaire.
How long until results are ready?
In most cases, results will be available in 2 business days from the time of specimen receipt. Results will be provided to the ordering physician. Patients can obtain test results by contacting their healthcare provider.
A POSITIVE result will be called to the provider and the patient. A NEGATIVE result will be called only if specifically requested on the lab order. Otherwise it will be distributed through normal lab reporting channels. Results will be reported to Public Health by the testing laboratory.
Do you bill insurance?
We do not currently accept health insurance. All tests are payable by credit card at time of service. An itemized receipt can be requested at time of payment which can be submitted to the patient’s insurance company for possible reimbursement.
COVID-19 antibody testing can detect the presence of antibodies in the blood to SARS-CoV-2 due to past exposure to the virus. This test is not for diagnosing active infections. Negative test results indicate that no protective antibodies were detected in the blood sample while positive test results mean protective antibodies were detected in the blood. If a person believes they have an active infection or if they are feeling ill, the antibody test is not recommended, and they should contact their healthcare provider to obtain an order for the COVID-19 RT-PCR diagnostic test instead. The patient must be symptom free (asymptomatic) for a minimum of 10 days before testing.
A COVID-19 Antibody test order form must be completed by a healthcare provider/physician.
The form must accompany the blood sample when submitted to NKGen Biotech for processing or faxed to NKGen Biotech if referring patient to our facility for on-site collection.
Patient blood draws can be performed by a healthcare provider or on-site at the NKGen Biotech facility.
To schedule a blood draw at NKGen Biotech America in Santa Ana, CA contact NKGen Biotech at 949-396-6830.
If the blood draw is performed at NKGen Biotech, the sample will be prepared and processed on site. If the blood is drawn at another healthcare providers site, the sample must be collected and prepared for shipment to NKGen Biotech as per sample prep procedures along with the test order.
What does the test measure?
The test detects the presence of antibodies indicating that a person had an immune response to SARS-CoV2 (COVID-19). A positive result indicates a previous exposure to COVID-19 causing the body to develop antibodies.
What specimen is required?
This test requires a venous blood draw to detect COVID-19 IgM/IgG antibodies in the blood.
What do the test results mean?
Antibodies in the blood indicate a previous COVID-19 infection. Antibodies typically develop within 14 days after the onset of symptoms although some individuals previously infected with COVID-19 may not have shown any symptoms but will still have a detectable antibody response.
How to order?
If the ordering physician is collecting the specimen, send blood specimen (collected as per specimen collection guidelines) along with the completed COVID-19 Test Order Form to NKGen Biotech for processing.
If the patient will be sent to the NKGen Biotech facility for testing, the doctor must fax completed order form to 949-861-9565 (FAX) prior to the patient calling for an appointment. After the test order has been faxed, patients should call NKGen Biotech at 949-396-6830 to set up an on-site collection appointment. Payment will be collected over the phone at the time of scheduling.
How long until results are ready?
In most cases, results will be available on the same day of testing. Results will be provided to the ordering physician. Patients can obtain test results by contacting their healthcare provider.
Do you bill insurance?
We do not currently accept health insurance. All tests are payable by credit card at time of service. An itemized receipt can be requested at time of payment which can be submitted to the patient’s insurance company for possible reimbursement.