Covid19 Testing Palm Beach Gardens | Coronavirus Antibodies test

Covid-19 Saliva Testing Is Here

TEST FOR COVID-19 IN PALM BEACH COUNTY TODAY WITH OUR RAPID SALIVA TESTING

COVID-19 SALIVA TESTING IN PALM BEACH GARDENS IS UNIQUE IN 4 WAYS

You don’t have to stick an uncomfortable swab up your nose, which will increase testing compliance. This also protects healthcare workers from potential exposure to sick patients and works around worldwide swab shortages. We also found that expensive preservatives are not needed to test saliva, which lowers the costs.

COVID-19 Saliva Testing Is Extraction-free

Nucleic acid extraction is time-consuming and expensive, and there have been worldwide shortages of the supplies needed to do it. For SalivaDirect™, Yale University has worked out how to skip this step, making it more accessible.

Accurate COVID-19 SALIVA TESTING

Vitality Sciences’ SalivaDirect method reflects 100% Clinical Specificity and 94% Clinical Sensitivity.

COVID-19 SALIVA TESTING IS FLEXIBLE

While many labs have similar equipment, they may be from a different company, and all of these need to be authorized by the FDA. We are aiming to validate our method with as many different variations of equipment and reagents as possible to allow labs to work with what they have and to prevent shortages. If your equipment isn’t on our list, let us know and we will work with you.

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WHAT IS SALIVADIRECT™ COVID-19 SALIVA TESTING?

HOW DOES SALIVADIRECT™ WORK?

It’s actually very simple. Our body’s IgM’s are the first line of defense in fighting the virus. If you are positive for IgM, it means you have been exposed to the virus within the past 3-5 days . A positive test means you have the virus and should self quarantine for at least 14 days. An IgG positive test means that you were exposed to the virus 3-4 weeks ago and now have the antibodies to fight the disease.

RAPID COVID-19 TESTING PRIORITY SERVICE

FOR PRIORITY SERVICE, PLEASE CALL US DIRECTLY AT 561-767-8225.

WHILE WE DO ANSWER EMAILS AS QUICKLY AS POSSIBLE, IT IS BEST TO CALL DIRECLY. EVEN DURING NON-OPERATING HOURS CALLS ARE FORWARDED TO A VITALITY SCIENCES EMPLOYEE WHO WILL GET YOU SITUATED WITH YOUR RAPID COVID-19 TEST.

SARS-CoV-2 / COVID19 / CORONAVIRUS TESTING REQUEST FORM

THANK YOU SO MUCH FOR YOUR INTEREST. ONE OF OUR COVID-19 TESTING EXPERTS WILL BE WITH YOU SHORTLY!

saliva testing covid-19 palm beach gardens

SALIVADIRECT™ AND STABILITY FOR COVID-19 TESTING

Stability of spiked-in saliva samples used for the limit of detection experiment was determined by placing 3 different concentrations (12, 25, and 50 copies/µL) for 7 days under different temperature regimes (4°C, room temperature, and 30°C). Results were compared to results obtained in the limit of detection experiment (fresh). Samples were treated with ThermoFisher Scientific proteinase K and tested with the ThermoFisher TaqPath RT-qPCR kit on the Bio-Rad CFX96. Overall, samples were stable under each condition for at least 7 days.

SALIVADIRECT™ AND CROSS-REACTIVITY FOR COVID-19 RAPID TESTING

In addition to cross-reactivity tests performed by the CDC, Yale has tested SalivaDirect™ on 52 saliva specimens collected from adults during the 2018/2019 and 2019/2020 (pre-COVID19) autumn/winter influenza seasons and detected 51 negative, and 1 invalid results.

covid 19 saliva testing in palm beach gardens | Salivadirect

CLINICAL VALIDATION OF COVID-19 SALIVA TESTING

Performance of SalivaDirect™ was compared to the authorized ThermoFisher Scientific TaqPath RT-PCR COVID-19 kit by testing 37 paired positive and 30 paired negative nasopharyngeal (NP) and saliva samples. Nasopharyngeal swabs and saliva were collected from inpatients and healthcare workers in the Yale-New Haven Hospital. Saliva was collected in sterile urine cups or 5 mL tubes without addition of any preservatives. The ThermoFisher Scientific TaqPath COVID-19 combo kit combines RNA extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit with a multiplex RT-PCR diagnostic assay targeting 3 regions of the SARS-CoV-2 genome (N, S, and ORF1ab). For SalivaDirect™ we used the ThermoFisher Scientific proteinase K, ThermoFisher Scientific TaqPath RT-PCR kit, and Bio-Rad CFX96 instrument.

Covid 19 saliva testing clinica validation

Yale University selected the positive and negative pairs based on preliminary results of our modified research protocol based on the US CDC primer-probe sets. Out of the 37 nasopharyngeal swabs that were tested with the TaqPath COVID-19 kit, three specimens tested negative (Ct value cut-off of 37). However, earlier results with the modified CDC assay indicated a (weakly) positive signal, and the paired saliva specimen tested positive with both SalivaDirect™ and the TaqPath COVID-19 kit. Two saliva specimens tested negative for SalivaDirect™ while the NP swab and saliva tested positive or inconclusive with the TaqPath COVID-19 kit.

All negative NP and saliva specimens tested negative with both the TaqPath COVID-19 kit and SalivaDirect™.

FAQ

What is an IgM and what is an IgG? Upon infection with the SARS-CoV-2 virus, the patient’s immune system tries to fight the virus by producing blood- circulating molecules known as antibodies. IgM is a class of antibodies that appears early after an infection (as early as 3-5 days).

IgM is the body’s first line of defense against a foreign antigen. IgG is another class of antibodies that appears later and gradually replaces the IgM antibodies.

Usually, IgG antibodies appear in the blood circulation within 3-4 weeks after initial infection. The presence of SARS-CoV-2-specific IgM and/or IgG antibodies in the blood of a patient is a strong indication that the patient has been infected with the SARS-CoV-2 virus.

1.How long does it take to develop the IgG & IgM antibodies after exposure to the Coronavirus?

A.IgM as early as 3-5 days. IgG as early as 3-4 weeks post infection.

2.What does a positive IgG result mean?

A. Most likely the individual was exposed at least 3 – 4 weeks prior to testing.

3.What does a positive IgM result mean?

A. IgM is the body’s first line of defense against a foreign antigen, so the individual was recently exposed to an infection (as early as 3-5 days)

4.If neither are positive, does this mean the patient was never exposed?

A. No, only the Real Time RT-PCR,DNA, swab test is a current indicator searching for the presence of SARS-CoV-2.

5.If a patient shows the presence of the antibodies, does this mean they cannot become infected with the virus in the future?

A. If the IgG is positive, there is a good chance the individual’s body built a defense against the virus.

6.How long will it take to receive results?

A. Within 24hrs

7.Is this an at home test?

A. No, this requires a venipuncture by a healthcare professional and will be tested in our CLIA certified High Complexity Lab

8.Who can order this test?

A.Physicians or Patients that will have their blood drawn by a healthcare professional.

9.How do I order COVID-19 IgG & IgM antibody testing?

A.Log into your online account, create a new requisition on your patient and use order code #C19P. Ship the blood to us using our transport boxes.

10. Can I send my patients to a draw site to be collected for this test?

A.Yes

11.Can a mobile phlebotomist be sent to my patients for this test?

A.Yes

12.What are the accepted specimen requirements, stability, shipping protocols?

A.Serum in an SST tube. Spin tube after 15min of draw. Ship ambient and it is stable for 48hrs.

13.What is the test methodology for COVID-19 IgG & IgM Antibody Testing?

A.Chemiluminescense ImmunoAssay

14.How is your test different from other rapid at-home antibody tests?

A.This is not an “at home test”. This test is performed at a CLIA certified lab that is CAP accredited.

15.What is the clinical specificity of this test?

A.97.50%

16.What is the clinical sensitivity of this test?

A.89.89%

17.Does Access accept insurance for this testing?

A.No

Get Started Today with Your COVID-19 Testing Today!

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