LAb PCR
Detect a Recent COVID-19 Infection
Serology antibody tests determine whether a person has recently had a COVID-19 infection. These tests should not be used to determine immunity status. Results available 48 to 72 hours after sample arrival at the laboratory.
Assays: DiaSorin IgM and IgG, Beckman Coulter IgG, Siemens and DIaSorin IgM, IgG and Total*.
*These tests are only for use under the Food and Drug Administration’s Emergency Use Authorization. This laboratory-developed test has been validated in accordance with CLIA and FDA’s Guidance Document (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Document). This test service has not been FDA cleared or approved.
How to Use
PREPARE THE SWAB
Remove swab from the sterile pouch without touching the swab tip
SWAB NOSE
Insert at least 1 cm (1/2 inch) and rotate in place for 10-15 seconds
INSERT & SNAP
Insert sample into the transport tube and snap the swab at the breakpoint
SEAL
Securely tighten the cap on the transport tube and prepare
What Will My Results Tell Me?
Your test results will confirm whether or not you are actively infected with COVID-19.
- Positive Results
If your results are positive, limit your exposure to other people and monitor your symptoms. As the CDC instructs, please alert healthcare providers of your test results before receiving medical care. However, do not delay seeking care if you are experiencing a medical emergency.
- Negative Results
If your results are negative, the virus was not detected in the sample you provided. However, tests may not detect the virus in early stage infections or poor quality nasal swab samples. If you were exposed to COVID-19 but received negative test results, follow up with a healthcare provider for further evaluation.
You will have the opportunity to speak with a licensed physician to discuss your test results.
- Incoclusive Results
It is possible for your test results to be inconclusive. This can happen for a variety of reasons. A licensed physician will contact you for further evaluation.
Senneca Dx partners only with CLIA-certified 1 laboratories that have validated reverse transcriptase polymerase chain reaction (RT-PCR) assays that detect the virus at low levels.* These assays include the Hologic Aptima, Roche Cobas, and EuroImmune EURORealTime assays. These tests identify the genetic material of SARS-CoV-2, the virus that causes COVID-19. The lowest level where the assay can reliably detect the virus is called the limit of detection (LoD). Senneca DX laboratory partners offer best-in-class assays that demonstrate a limit of detection (LoD) of ~100 copies of viral RNA per milliliter of transport media.2
*This test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This laboratory-developed test has been validated in accordance with CLIA and FDA’s Guidance Document (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Document). This test service has not been FDA cleared or approved.
1 Certification. All testing shall be in accordance with applicable state and federal testing requirements for clinical laboratories. The labs maintain all necessary licenses, permits, accreditation and certifications required under applicable law, rule or regulation for clinical laboratories to perform the tests referred herein, including, without limitation, approvals under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988.
2 Arnaout R, Lee RA, Lee GR, et al. SARS-CoV2 Testing: The Limit of Detection Matters. Preprint. bioRxiv. 2020;2020.06.02.131144. Published 2020 Jun 4. doi:10.1101/2020.06.02.131144
More Information: Patients | Healthcare Providers
PCR (Polymerase Chain Reaction) is the gold standard for SARS CoV-2 diagnostic virology and the most accurate laboratory method for detecting the SARS-CoV-2 virus. [1] Performance of these assays is dependent on the amount and quality of template RNA purified from human nasal matrix specimens.
Hologic Aptima Assay
The Hologic Aptima Assay with its unique technology of transcription-mediated amplification (TMA) increases the rate of amplification compared to PCR. This assay amplifies and detects two conserved regions of the ORF1 a/b gene. In combination with the highly automated Hologic Panther PCR instrument, this enables both a low LoD and quick turn-around-time. The LoD of this assay is 83 copies/mL.
Roche Cobas Assay
The Roche Cobas also has a low LoD. The Roche Cobas assay targets the ORF1 a/b and E (envelope) genes. The LoD of this assay is 46 copies/mL.
EuroImmune EURORealTime Assay
The EuroImmune EURORealTime SARS-CoV-2 assay targets two defined sections within the ORF1 a/b and N genes. The LoD of this assay is 150 copies/mL.
Gandhi, R.T., Lynch, J.B., & del Rio, C. (2020). Mild or Moderate Covid-19., 1757-1766. DOI: 10.1056/NEJMcp2009249
Hologic Aptima Assay
To assess clinical performance, 65 contrived positive and 50 negative specimens were tested.
The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG assay was evaluated in 192 serum and plasma samples from symptomatic individuals diagnosed with SARS-CoV-2 by PCR methods from France and the United States. The positive percent agreement for the 51 samples taken >18 days after a positive PCR was 100%.
Clinical Evaluation Results
- 65/65 contrived positive specimens tested positive for SARS-CoV-2, no false negative results
- 50/50 negative specimens tested negative for SARS-CoV-2, no false positives
- 100% Positive Percent Agreement
- 100% Negative Percent Agreement
Roche Cobas Assay.
Clinical performance of this assay was evaluated using 50 contrived positive specimens and 100 negative specimens
Clinical Evaluation Results
- 50/50 contrived positive specimens tested positive for SARS-CoV-2, no false negative results
- 100/100 negative specimens tested negative for SARS-CoV-2, no false positives
- 100% Positive Percent Agreement
- 100% Negative Percent Agreement
EuroImmune EURORealTime Assay
Clinical Evaluation Results
- 48/50 tests agreed with expected positive result
- 30/30 tests agreed with expected negative result, no false positives
- 96% Positive Percent Agreement
- 100% Negative Percent Agreement
These assays are nucleic acid amplification in vitro diagnostic tests intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasal nares swab specimens obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria including from individuals without symptoms or other reasons to suspect COVID-19 infection. These assays are for use only under Emergency Use Authorization (EUA) in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 Nasal Viral Test Collection Kit is intended for use by healthcare professionals. The COVID-19 Nasal Viral Test Collection Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
