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 – 14 hours** for travel testing. Typically, the quickest way to get your test results is to have 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 traveling.

* Appointment times for travel testing are 8:30 am – 1:30 pm. The 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 the same or next day of sample receipt from the 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 testing for Hawaii travelers. Hawaii travelers must get tested with preferred lab vendors by the state of Hawaii.

Get tested with a PCR 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 traveling. Below are some resources for travel information:

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

How can I book an appointment and what are your hours?

You can book an appointment by clicking on Book Appointment.

Our business hours are from 8:30 am to 5:30 pm. Our travel collection hours are between 8:30 am – 1:30 pm Monday through Friday, except Tuesdays. An appointment is required, but we will try to accommodate walk-ins as necessary.

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

Our COVID-19 Testing for Travel to China Package includes one NAAT RT-PCR and 2-3 antibody tests, documentation, and same-day results. 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.

RT-PCR tests used for travel to other countries are also released within the same day between 7-10 pm.

The China Package is $400 which includes the NAAT RT-PCR and IgM Antibody (S Protein and N Protein as needed) Test, all documentation necessary for submission, submission to the consulate, and same-day processing. (https://targetdxlab.com/covid-testing-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.

Is the specimen type (i.e., serum, plasma, venous serum) on the test report?

Yes, the report explicitly states the specimen type used for the test. For example, we use serum/venous serum or plasma for for the antibody test or nasopharyngeal for the RT-PCR test.

Will the test report indicate the specific testing method (i.e., colloidal gold, Immunoassay)?

We use two methods for the Antibody test which are 1) Immunoassay: enzyme-linked immunosorbent assays (ELISA) for combine IgM, IgG, and IgA and 2) Colloidal Gold/Lateral Flow (IgM only, IgG only). We do have both the anti-S and the anti-N.

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

These are indicated in the report.

Does TargetDx have its own CLIA-certified lab? If so, where?

TargetDx Laboratory is a fully certified CLIA Laboratory by the Laboratory Field Services (LFS) and the State of California for High Complexity Testing: State ID: CLF-90001713, CLIA ID: 05D2194953. All methods and platforms employed by TargetDx Laboratory are FDA EU approved.

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.

Do you have another location where I can get my samples collected?

Please email us for information. TBA.

How do I get my test result?

Testees will register for an account online on our patient portal. When test results are released between 7-10 pm the same day, the Testee will be sent an email with an encrypted and password-protected PDF copy of their result, and instructions on how to access their report on their portal. Results are also submitted to the SF Chinese Consulate-General e-mailbox for China travelers.

Why are the COVID-19 test results for travel to China sent to the SF Chinese Consulate-General e-mailbox?

Results for COVID-19 testing for travel to China are 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 long does it take to receive the test results of Covid-19 test?

If you book the same day, you will get it on the evening of your collection appointment between 7-10 pm.

We will email a copy of your test result as an encrypted and password-protected PDF file, as well as provide you with a patient portal for access. Please make sure to check your spam and junk mail. If you have not received your results by 9 PM, please email info@targetdxlab.com or log in to your patient portal to access your result.

For china travelers, results are sent to the SF Chinese Consulate-General e-mailbox.

Can I order this test online for myself?

Yes, you can order the test online by clicking on Book Test.

Is COVID-19 testing for travel covered by my insurance?

Insurance does not typically cover travel testing. However, some insurance might. You should call your insurance and find out. You will first need to pay out of pocket and submit for reimbursement per your insurance company’s instructions.

How does the vaccine affect my antibody test result?

We have two antibody tests, the S protein antibody test and the N protein antibody test. If you have been vaccinated by Moderna, Pfizer or Janssen, your S antitbody will most likely be positive. If you have previously been infected with the COVID19 virus, then your N antibody would be positive. If you have been vaccinated by the mRNA vaccines, and never been infected, you may have a positive S antibody and a negative N antibody.

We have both the Immunoassay and lateral flow assay (aka colloidal gold) platforms to test for N and S protein. Our N Protein immunoassay has a specificity of 99.8% and a sensitivity of 99.5%. Our S Protein immunoassay has a specificity of 100% and sensitivity of 96.6%. More than 6,000-10,500 samples were tested for validation for the immunoassay.  Our S Protein lateral flow test has a sensitivity and specificity of 100% for IgM and 97.5% for IgG. More than 80 samples were tested for validation for the lateral flow test. Both tests are FDA EUA approved.

To account for vaccinated individuals, antibody testing requirements have been updated by the Chinese Consulate-General. Travelers to China are required to have an anti-S antibody test, and an anti-N protein antibody test if positive on the S Protein. If you have been vaccinated, you may be and are likely to be positive for the S Protein. You will then be tested for the N protein. If you are S Protein Positive, N Protein Negative, RT-PCR Negative, and Vaccinated with Moderna, Pfizer or Janssen, you should be fine to travel to China. Should you test positive on the S Protein, we will process your sample on the N protein as required by the Chinese Consulate General at no extra cost.

What if I have not received my results?

Results are normally sent out by email and through the patient portal within the same day between 7-10 pm. If you have not received them by 9 pm, 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”.

How do the mutations affect our NAAT RT-PCR COVID-19 Test?

Our molecular test detects multiple (ORF1, S, and N) 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. Our RT-PCR test covers all variants.