Covid- 19 Testing for Travel

Fast, Accurate COVID-19 Testing for Travel

More countries, states, and companies are requiring a negative COVID-19 test prior to travel or entry.  With rapid and accurate testing, TargetDx Laboratory can provide expedited same day test results*.

TargetDx Laboratory is a CLIA certified lab and we offer both COVID-19 PCR Viral Test and COVID-19 Antibody Test. These tests are only authorized for Emergency Use Authorization (EUA) and performed by laboratories in the United States who are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

TargetDx Laboratory’s COVID-19 test results are accepted for most travel interstate and internationally. Currently we are not doing to testing for Hawaii travelers. Hawaii travelers must get tested with preferred lab vendors by the state of Hawaii.

TargetDx Laboratory is an approved testing institution by the Chinese Consulate General in San Francisco for both COVID-19 Nucleic Acid and Serology IgM Antibody tests for travel to China. We offer expedited test services for travelling to China. Learn more about our Covid testing for travel to China.

 

COVID-19 PCR Viral Test (COVID-19 Nucleic Acid Test)

COVID-19 PCR Viral Test is a molecular test for active infection, and it involves collecting swab specimens from your nose or throat.

The COVID-19 PCR Viral Test is a nucleic acid amplification test (NAAT) utilizing real-time reverse transcription polymerase chain reaction (RT-PCR) intended for the qualitative detection of nucleic acid from SARS-CoV-2. This assay detects ORF1ab, N, and S genes of SARS-CoV-2, plus an MS2 phage control.

We expect the new variant from the UK, B.1.1.7, to be detected by our test because it screens for three regions of interest:

  • S Gene (Spike protein)
  • N Gene (Nuclear Capsid protein; at virus’ core)
  • ORF Gene

The UK B.1.1.7 variant has most of its mutations in the S protein, so even if the RT-PCR does not detect the variant’s S gene, it still detects both N & ORF genes.

The COVID-19 PCR Viral Test currently performed by TargetDx Laboratory has been validated for FDA EUA for the current pandemic. Based on a validation study using 20 bronchoalveolar lavage (BAL) and 20 nasopharyngeal (NP) swabs, the test was able to detect 100% of positive specimens accurately.

The typical turnaround time is 8 – 24 hours** for travel testing. Typically, the quickest way to get your test results is having them sent to you through a secure online portal or to your email in an encrypted and password protected format. We offer expedited services for patients travelling.

* Appointment times for travel testing are 8:30 am – 1:30 pm. Last appointment for expedited same day test results is 1:30 pm.

**If a test comes back inconclusive, it will be retested and may incur a longer turnaround time (usually within completed within 2 days of sample receipt from lab).

COVID-19 PCR Viral Tests we offer are:

  • COVID-19 PCR NAAT RT-PCR and Antibody Test (IgM), Travel, 14-hr turnaround
  • COVID-19 PCR NAAT RT-PCR and Antibody Test (IgM), Travel, 24-hr turnaround
  • COVID-19 PCR NAAT RT-PCR Test Only, Travel, Same Day Results
  • COVID-19 PCR NAAT RT-PCR Test x 2, Travel, 24-hrs apart

COVID-19 Antibody Test

The COVID-19 antibody test has been approved to identify recent or prior infection to SARS-CoV-2 and it is not intended to diagnose a current infection or to rule out an active COVID-19 infection. It involves a simple blood draw.

For the antibody test (post-infection), TargetDx Laboratory utilizes an enzyme linked immunoassay (ELISA) (IgM, IgG, and IgA combined) and a colloidal gold assay (IgM or IgG independent) for the in-vitro qualitative detection of antibodies to SARS-CoV-2 in human serum and plasma. The test is intended to aid in the determination of the immune reaction to SARS-CoV-2.

The antibody tests currently offered by TargetDx Laboratory have specificity values of 99.5% which keeps false positive results to a minimum. The antibody test sensitivity values are approximately 99.5% to 100%.

Our antibody tests have met validation standards and have been granted Emergency Use Authorizations (EUA) by the FDA for public health and clinical use.

Turnaround time for the COVID-19 Antibody Test is typically 8-24 hours from the time the specimen is received in our laboratory. We offer expedited services for patients travelling.

COVID-19 Antibody Tests we offer are:

  • COV19PCR NAAT RT-PCR and Antibody Test (IgM), Travel, 14-hr turnaround
  • COV19PCR NAAT RT-PCR and Antibody Test (IgM), Travel, 24-hr turnaround
  • COVID-19 Antibody Test (IgM), Travel, Same Day Result

Site Testing

TargetDx Laboratory also provides normal (non-travel) testing to the public. We work with schools, government agencies, private sectors, and more. If you would like to set-up testing for your organization, please email us.

FAQ for Travel

What are the requirements for testing for travel?

Each country, state and airline have their own requirements for travel. TargetDx COVID-19 PCR Viral Test results are accepted for most travel interstate and internationally. TargetDx Laboratory is currently not doing to testing for Hawaii travelers. Hawaii travelers must get tested with preferred lab vendors by the state of Hawaii.

Get tested with a viral test 1-3 days before you travel. Keep a copy of your test results with you during travel in case you are asked for them. Do NOT travel if you test positive.

Please check travel testing requirements by the country or state to which you are travelling. Below are some resources for travel information:

There are more sites for information. Please do your due diligence and check the testing requirements before travelling to a state, country or through an airline.

Lab & Collection Hours

Our lab is open 9am-5pm Monday through Friday. Our collection hours are 8:30am – 12pm Monday through Friday, and 1pm – 2:30pm Monday through Thursday. An appointment is required.

Please note that for Expedited Results (same day), our cut-off time for receiving samples is 1:30pm. Next Day Results are available between 2-4pm the next day.

Booking an Appointment

Whether for Travel or Normal (non-travel) testing, please visit our website at https://targetdxlab.com/ and click the blue “Book Your Appointment” box. This will allow you to register as a patient, book an appointment, and pay for the test(s) you have selected.

The cost for travel testing is $400 which includes the PCR and Antibody test, required documents, and same day test results. We confirm positive antibody tests with another acceptable platform (ELISA, Colloidal Gold) at no extra charge. We want to ensure that the results we provide are most accurate.

Travel Testing Appointments, Payment, and Refund Policy

Appointments for travel testing can be made here.

A payment must be paid to reserve an appointment slot.

Refund Policy:

  • Cancellation 5 days prior to appointment will be refunded. A transaction fee is incurred.
  • Cancellation 3 days prior to appointment will incur a 30% charge fee.
  • Cancellation 2 days prior to appointment will incur a 50% charge fee.
  • No refunds are provided for cancellations within 24 hours of appointment.

Please do not come to the lab if you have symptoms. Nasal swab is done in your car. Blood draw is done inside the clinic.

What does the COVID-19 Testing for Travel to China Package include?

Our COVID-19 Testing for Travel to China Package includes PCR and Antibody tests, documentations, 24 hour or 14-hour turnaround time for tests. These tests must be done 2 days prior to the flight. Both SARS-CoV-2 NAAT RT-PCR and Antibody tests are required for travel to China.

Are both nucleic acid and serology IgM antibody tests available at TargetDx Laboratory?
  • Both nucleic acid and Serology (IgG, IgM, and IgA combined, and individual testing for IgM and IgG) antibody tests are available at TargetDx. The following tests are available:
    • COVID-19 NAAT RT-PCR Viral Test (detect ORF1ab, N, and S genes of SARS-CoV-2)
    • COVID-19 Antibody Test Enzyme Linked Immunosorbent Assay (detects IgM, IgG, and IgA combined)
    • COVID-19 Antibody Test Colloidal Gold (detects IgM or IgG independently)
Can the test reports be produced within 48 hours after the collection of the specimen?

Yes, the reports are produced within 8 – 24 hours.

Does TargetDx Laboratory have the testing licenses from the US relevant health departments?

Yes, we are in full compliance with the federal and CA state CLIA regulations and use only FDA EUA approved tests. We can provide FDA letters, performance summary of our platforms, and copies of our CLIA licenses.

Are the words Serum, IgM, Venous blood (Venous) explicitly marked in the current test reports from TargetDx Laboratory?

Yes, the report explicitly states that our test detects Venous Serum or Plasma IgM, IgG, IgA, or IgM (only) or IgG (only).

Can the test reports also indicate specific testing methods including Colloidal gold, Chemiluminescence, Enzyme-linked immunosorbent assay? If not the above three testing methods applied, can other specific method (Methodology) be indicated in the test reports?

The method used for our Antibody test method is an Immunoassay: enzyme linked immunosorbent assays (ELISA) for combine IgM, IgG, and IgA; or Colloidal Gold (IgM only, IgG only).

The method for the Nucleic Acid Amplification Test (NAAT) is Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

This are indicated on the reports.

Does TargetDx have its own lab and where? If not, please provide the cooperative lab name.

Yes, we are located at 6541 Via Del Oro, Suite B, San Jose, CA 95119

Our phone is 219-510-0120

Emails regarding the test can be sent to info@targetdxlab.com

How are the Testees informed of the test results? Do the Testees need to register online by creating accounts with passwords and the test results will be sent to the accounts after the tests resulted? Or TargetDx send test results to the Testees by e-mails?

We have a patient portal, but we find that it is more efficient for patients to get a direct email. We can email them their result as an encrypted and password protected PDF file. Copies of the PDF reports are also sent to the SF Chinese Consulate-General e-mailbox.

Why are the COVID-19 test reports for travel to China sent at the same time to the SF Chinese Consulate-General e-mailbox?

Copies of the PDF reports for COVID-19 testing for travel to China are also sent to the SF Chinese Consulate-General e-mailbox at the request of the Consulate-General. This allows them to confirm the authenticity of the report submitted by the patient.

Notice on the Requirement Adjustment of the Nucleic Acid rt-PCR and IgM Serum Antibody Tests

http://www.chinaconsulatesf.org/eng/zytz/t1841433.htm

There has recently been a sharp increase of imported COVID-19 cases from the United States in China. Most of them can be traced to infection in transit, while a few are related to faulty operations of intermediary agencies and laboratories or to passengers’ nonobservance of home quarantine requirements after testing. The U.S. Centers for Disease Control and Prevention (CDC) counted a total of nearly 17 million confirmed cases in the United States by December 18, and another 1.2 million to 2.3 million new cases are expected to be reported every week in early January 2021. To protect the health and safety of passengers and aircrew and prevent a resurgence of COVID-19 in China, the Chinese embassy and consulates in the United States once again recommend travelers avoid all nonessential and non-urgent travels. Passengers who have urgent need of travel please follow the test guidelines and requirements listed below:

  1. Starting from 0:00 on December 23, 2020 Pacific Time, IgM serum antibody test must be performed by medical professionals through venous blood sampling, and the test report should include the following terms: Serum, IgM, Venous, etc. Finger-prick blood testing is no longer accepted. The report also needs to clearly state testing methods, including: (1) Colloidal gold; (2) Chemiluminescence; (3) Enzyme-linked immunosorbent assay; (4) Others, please specify.
  1. Starting from 0:00 on December 23, 2020 Pacific Time, nucleic acid rt-PCR test report should include such terms as NAAT, RT-PCR, and specify sampling method, including: (1) Pharyngeal swab; (2) Nasopharyngeal swab; (3). Others, please specify.

III. In order to prevent infection from long-distance travel after testing, passengers traveling to China must get their samples for the nucleic acid rt-PCR and IgM serum antibody tests collected at the departure city and vicinity of their direct flight to China. The specific arrangements are as follows.

  1. At present, direct flights from the United States to China fly from Los Angeles, San Francisco, Seattle, New York, Detroit and Dallas.
  1. Passengers must allow for the time to take pharyngeal or nasopharyngeal swabs, venous blood and other sampling in the departure city and vicinity of their flight and wait in place for the test results before the flight. Upon receiving the reports, passengers should upload them immediately to apply for the health code for boarding.
  1. Collected samples must be tested at a laboratory institution that is on the list released by the Chinese embassy and consulates. Please have prior confirmation with your sample collecting institution whether the samples are tested in such a laboratory. The list of laboratories is listed on the Chinese consulate’s website, and it will be adjusted from time to time. Please pay close attention to the notices and reminders on the websites of the Chinese embassy and consulates.
  1. When applying for the health code, flight itinerary and proof of sampling at flight departure city and vicinity (such as clinic report, letter of proof, sampling-site photos or receipts, etc.) should be uploaded alongside with test reports and other materials. If the system does not have a special upload window for flight itinerary and proof of sampling city, please upload them in the window for submitting test reports.
  1. Starting from 0:00 on December 23, 2020 Pacific Time, the Chinese embassy and consulates in the United States will only accept test results from the laboratories on the list, and they will be reviewed in conjunction with flight itinerary, sampling city, etc.
  1. The airlines are only required to check the health code for international flights to China, but if your flight contains a domestic leg, there is a possibility that some airlines have additional requirements, or their staff have different understanding as to checking the code. Please check with your airlines in advance or choose not to go to your international departure city via connecting flights.
  1. The Chinese embassy and consulates will verify the authenticity of test results with sample collecting and testing institutions. Passengers are advised to agree to disclosure of relevant information by the institutions to the Chinese embassy and consulates, including test results.
  1. Passengers are strongly recommended to take personal protection very seriously to avoid infection in travel to the departure city and during the stay before departure. Please minimize public contact after testing. Some states have put in domestic travel restrictions or stay-at-home order, passengers are advised to inquire about local regulations in advance and comply.
  1. In case of any inconsistency between this Notice and the previous ones, this one shall prevail.
How quickly can I get my COVID-19 test results?

The typical turnaround time is 14-30 hours for travel testing. Typically, the quickest way to get your test results is having them sent to you through a secure online portal or to your email in an encrypted and password protected format. We offer expedited services for patients travelling to China and other international destinations.

Can I order this test online for myself?

You can email travel@targetdxlab.com or go to our website to book an appointment or get more information regarding appointments.

If you suspect you have active COVID-19 infection or have been exposed to the virus, contact your doctor or an authorized healthcare provider. If testing is right for you, your healthcare provider will direct you to where to get tested.

Are COVID-19 travel test covered by my insurance?

Travel testing is not covered by insurance. The patient can pay for the test out-of-pocket

Antibody testing is not covered by insurance unless deemed medically necessary by your physician.

Antibody Testing and Vaccines

When testing for antibodies, we utilize an antibody platform, which is ELISA (enzyme-linked immunoassay) and specific for the N-protein. If you have been vaccinated with the Pfizer, Moderna, or J&J vaccine, this usually does NOT show as positive, unless you have been previously infected (and dependent upon when you were infected). Our ELISA test has a specificity of 99.8% and a Sensitivity of 99.5%.

We also offer the antibody lateral flow (aka colloidal gold), which is specific for S-Protein. This allows us to differentiate between an IgM versus an IgG response. Because it is specific to the S-Protein, the lateral flow is expected to detect antibodies induced from the Pfizer, Moderna and J&J vaccines. Our lateral flow test has a sensitivity and specificity of 100% for IgM and 97.5% for IgG.

Should you test positive on the immunoassay test, we will process your sample on the colloidal gold to differentiate between IgG and IgM response at no extra cost.

Missing Tests Results

Results are normally sent out by email and through your portal within 24-48 hours after receipt at our laboratory. If you have not received them after 2 days, check your portal and in your spam and junk folders in your email. When checking your junk folder, you may need to do a search for “targetdxlab”. In any case, we will resend your results within 24 hours.

NAAT RT-PCR COVID-19 Test and Mutations

Our molecular tests detect multiple (3) SARS-CoV-2 Targets and an MS2 phage and has a sensitivity and specificity of >99.9. Since this test is designed to detect multiple genetic targets, the overall test sensitivity should not be impacted by current variant mutations.