Increased Options for COVID-19 Testing: Curative Product Offerings

Curative now offers more testing solutions as we continue to battle the COVID-19 pandemic. When booking an appointment for a COVID-19 test, it is important to know what options are available and which test to select. Here’s a break down of our product offerings so you can make an informed decision when booking your upcoming test:

RT- PCR Tests for COVID-19

  1.  Curative HT SARS-CoV-2 Test* (​​Laboratory-Developed Test; EUA application under review by FDA)
  1. Abbott Alinity m SARS-CoV-2**
  • FDA Emergency Use Authorization
  • Test results are confidential and delivered digitally, typically within 1-2 days after arrival at the lab
  • Specimen collection is self-collected under the direction and observation of a healthcare worker

A standard, lab based PCR test is a diagnostic nucleic acid amplification test (NAAT) that can tell you if you have a current infection. A NAAT is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. NAATs detect genetic material (nucleic acids) and specifically identify the RNA (ribonucleic acid) sequences that comprise the genetic makeup of the virus.

NAAT works by amplifying the virus’s genetic material, if any is present in a specimen. According to the CDC, NAATs can detect small amounts of SARS-CoV-2 and are unlikely to return a false-negative result.

Abbott ID NOW test for COVID-19**

  • FDA Emergency Use Authorization
  • Rapid molecular test for SARS-CoV-2 
  • Self-collected, anterior nasal swab
  • Specimen collection is observed and directed by a healthcare worker
  • Results delivered digitally to the patient, typically within 2 hours

While polymerase chain reaction (PCR) tests are molecular tests, not all molecular tests use PCR methodology. Molecular tests that are not PCR have a similarly high sensitivity rate compared to antigen tests. Molecular tests detect genetic material – the RNA – of the coronavirus and are sensitive enough to need only a very tiny amount of it. It is useful when same-day molecular results are needed or when a patient is symptomatic or exposed to COVID-19. 

Laboratory-based NAATs are considered the most sensitive tests by the CDC for detecting SARS-CoV-2, but also the longest to produce results. Results from Curative are delivered in 1-2 days. A lab PCR test can help to validate your results if you’ve taken a less sensitive test. 

~2 Hour RT-PCR Test for COVID-19

  • ThermoFisher Scientific Accula SARS-CoV-2 Test**
  • FDA Emergency Use Authorization
  • Available for symptomatic or asymptomatic patients
  • Test results are typically available same day
  • Specimen collection is self-collected under the direction and observation of a healthcare worker
  • This test is generally accepted anywhere a PCR test is required, check your organization’s requirements carefully

Rapid PCR results are typically available within an hour. These tests are offered as point-of-care  and self-administered tests, which mean they are more accessible, especially outside of a healthcare setting. The level of sensitivity for the detection of SARS-CoV-2 genetic material in a specimen varies depending on the type of NAAT. Rapid PCR tests are generally accepted in circumstances where a PCR test result is required; check your organization’s requirements carefully.

~1 Hour Rapid Antigen test for SARS-CoV-2

  • Abbott BinaxNOW COVID-19 Ag Card**
  • FDA Emergency Use Authorization
  • Specimen collection is a shallow nasal swab administered by a healthcare worker
  • Test results are delivered delivered digitally, typically within 1 hour

Rapid antigen tests usually detect the presence of a specific viral antigen, which means the person has a current viral infection. Currently, rapid antigen tests are emergency use authorized for point-of-care, lab, and self-administered testing. Curative offers rapid antigen tests that return results typically within 1 hour, but sensitivity is less than that of NAATs. According to the CDC, antigen tests perform best amongst symptomatic people. If symptomatic and receiving a negative rapid antigen test, it is still important to maintain social distancing and isolation until a Lab PCR can be performed. 

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At Curative, we’re pleased to offer these products to tackle the pandemic in a way that is most convenient and appropriate to the patient. When making an appointment at Curative.com, patients can see which tests are offered at each location and choose their site accordingly. If you have further questions on which test is most appropriate, please contact your healthcare provider. 

Antigen Tests: **For more information about the performance & intended use of the Abbot BinaxNOW COVID-19 Ag Card, please see the following EUA, patient fact sheet, & provider fact sheet.

Abbott Alinity m PCR Tests: **For more information about the performance & intended use, please see the following EUA, patient fact sheet, provider fact sheet

Accula SARS-CoV-2 Test: **For more information about the performance & intended use, please see the following EUA, patient fact sheet, provider fact sheet

Abbott ID NOW Test: **For more information about the performance & intended use of the Abbott ID Now COVID-19 molecular test please see the following EUA, IFU, patient fact sheet, provider fact sheet

*Validated laboratory developed test (LDT) that has not been FDA approved or cleared.

**These tests have not been FDA cleared or approved, but have been authorized for emergency use by FDA (EUA). These tests have been authorized only for the detection of SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of these tests is only authorized for the duration of the emergency declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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