Novel Coronavirus Disease (COVID-19)

NKMax now offers both tests for COVID-19: Antibody and RT-PCR

Overview

NKMax offers 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.

We also offer 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 collected by a healthcare professional.

Both the COVID-19 RT-PCR and Antibody Tests, performed at NKMax America, 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.

Patients must contact their physician to order COVID-19 Tests.
A valid doctor’s order is required before testing.

COVID-19 IgG/IgM Antibody Test (for past exposure)

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.

How to Order the COVID-19 IgG/IgM Antibody Test

1. Complete a test requisition form

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 NKMax for processing or faxed to NKMax if referring patient to our facility for on-site collection.

2. Schedule a Blood Draw

Patient blood draws can be performed by a healthcare provider or on-site at the NKMax facility.

To schedule a blood draw at NKMax America in Santa Ana, CA contact NKMax at 949-396-6830.

3. Deliver to NKMax for processing

If the blood draw is performed at NKMax, 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 NKMax as per sample
prep procedures along with the test order.

Frequently Asked Questions for COVID-19 IgG/IgM ANTIBODY TEST

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.

This test requires a venous blood draw to detect COVID-19 IgM/IgG antibodies in the blood.

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.

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 NKMax for processing.

If the patient will be sent to the NKMax 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 NKMax at 949-396-6830 to set up an on-site collection appointment. Payment will be collected over the phone at the time of scheduling.

In most cases, results will be available within 1-2 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.

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 RT-PCR Test (for active infection)

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. 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.

How to Order the COVID-19 RT-PCR Test

1. Complete a test requisition form

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 NKMax for processing or faxed to NKMax if referring patient to our facility for on-site collection.

2. Schedule a Specimen Collection

Patient upper respiratory specimen samples can be collected by a healthcare provider or on-site at the NKMax facility.

To schedule an on-site swab collection at NKMax America in Santa Ana, CA contact NKMax at 949-396-6830.

3. Deliver to NKMax for processing

If the upper respiratory swab sample is collected at NKMax, 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 NKMax as per sample prep procedures along with the test order.

Frequently Asked Questions for COVID-19 RT-PCR Test

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.

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).

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.

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 NKMax for processing.

If the patient will be sent to the NKMax 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 NKMax at 949-396-6830 to set up an on-site collection appointment. Payment will be collected over the phone at the time of scheduling.

In most cases, results will be available within 2-4 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.

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.

On-Site Collection Available – Call for Appointment
949-396-6830

Must have a valid doctor’s order faxed to NKMax before scheduling

For more information on COVID-19, please visit the CDC website
https://www.cdc.gov/coronavirus/2019-ncov/

FDA Emergency Use Authorization Fact Sheets