Serology Testing Announcement
April 16th, 2020
We are pleased to announce that Primex Clinical Laboratories, Inc has completed the test validation to perform the Coronavirus Antibody, IgG and IgM tests for the 2019-Novel Coronavirus (SARS-CoV-2).
Coronavirus Disease 2019 or COVID-19 is the name for the respiratory syndrome caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Primex will be using the serological test kits for IgG and IgM, provided by Diazyme Laboratories, Inc., a commercial diagnostics manufacturing company. The sample requirement is serum (SST) or EDTA plasma (Lavender Top Tube) and the tests will be performed on a fully automated chemiluminescence analyzer.
The availability of these two serological tests for SARS-CoV-2 can provide important information on a patient’s COVID-19 infection status. After infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies. The Diazyme IgM and IgG tests are able to detect these antibodies and the kits have high specificity, sensitivity and clinical agreement with samples confirmed with PCR methods (RT-qPCR)”.
- This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic assay should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- Not for the screening of donated blood.
Primex Test codes: COVID-19 IgM: 8365 COVID-19 IgG: 8364
CPT code: COVID-19 IgM: 86769 COVID-19 IgG: 86769
Please contact your Primex Sales Representative, or the Primex marketing department at 818-779-0496 for more information on test ordering, specimen collection supplies and specimen pick up.
Test Announcement for 2019-Novel Coronavirus (COVID-19)
March 16th, 2020
We are pleased to announce that the assay kit that Primex Clinical Laboratories, Inc. validated has received approval from the FDA to perform 2019-Novel Coronavirus (2019-NCoV) testing. The new test service will be provided as a laboratory developed test (LDT), pending further review by the FDA under emergency use authorization which Primex will submit per FDA guidance.
Coronavirus Disease 2019 or COVID-l9 is the name for the respiratory syndrome caused by infection with severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). Testing is limited to qualified laboratories designated by the CDC, and we are pleased that Primex as a high complexity lab is approved to perform this testing.
Primex has received samples from BEI that are positive for SARS-CoV-2. We have used these samples for our LDT validation testing, and for quality control purposes. We have received testing supplies from our vendors and anticipate testing and receiving patient samples for testing for COVID-19 on March 19th, 2020.
The Primex test is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid of SARS-CoV-2 from upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, broncho-alveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet CDC criteria for 2019 NCoV testing.
Positive results are indicative of active infection with 2019 NCoV but do not rule out bacterial infection or co-infection with other viruses. Laboratories will be required to report all positive results to the appropriate public health authorities.
Negative results do not preclude 2019 NCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Primex will accept nasopharyngeal, nasal or oropharyngeal samples which should be collected using only swabs with a synthetic tip, such as nylon or Dacron®, and an aluminum or plastic shaft. Calcium alginate swabs and cotton swabs with wooden shafts are unacceptable. Place swabs immediately into sterile tubes containing 2-3 ml of viral transport media. Refrigerate the sample until specimen pick up.
Please contact your Primex Sales Representative or the Primex Marketing Department at (800) 961-7870 for more information on test ordering and specimen collection.
COVID-19 Testing at Primex
Primex has been offering COVID-19 testing since March 18, 2020. We have run thousands of COVID-19 PCR and serology samples to date. Our testing numbers continue to climb as we work to deliver meaningful and timely results to our community.
Specimen Collection, Handling and Processing Protocol For Samples Collected from Persons Under Investigation (PUI) for COVID-19 or with Conﬁrmed COVID-19
Out of consideration for other patients and our employees, we respectfully ask that individuals who meet the criteria for risk of having COVID-19 do not enter Primex Patient Service Centers. Requests for COVID-19 testing must be ordered by a physician or other authorized healthcare provider.
Example of collection procedure from Copan Diagnostics
SARS-CoV-2 — Specimen Collection Instructions
Specimen Requirements – Nasopharyngeal (NP) or oropharyngeal (OP) swab in viral transport medium, NP or OP washes/aspirates in sterile cups, bronchial washings or bronchoalveolar lavage (BAL) specimens in sterile cups.
- Tilt patient’s head back 70 degrees.
- While gently rotating the swab, insert swab into nostril (until resistance is met at turbinates).
- Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Place in viral transport medium tube and cut off the applicator tip.
- Take a dry polyester swab, insert into mouth, and swab the posterior pharynx and tonsillar areas. (Avoid the tongue.)
- Place tip of swab into the viral transport medium tube and cut off the applicator tip.
Nasal Swab Collection
Insert swab 2-3 cm into one naris, rotate against the anterior nasal mucosa for 3 seconds, repeat this procedure using the same swab in the second naris. Place the swab into the transport media vial and break the swab using the indent on the swab stalk. Close the cap of the transport vial firmly and transport specimen to the laboratory.
Write the patient name, date and time of collection on the specimen container. Write “Coronavirus” on the specimen label. Place the specimen in a plastic bag and label this inner bag “Hazardous”. Then place the bagged specimen into another specimen bag along with your Primex Test Requisition Form.
Refrigerate sample until specimen pick up. The Primex courier will transport the specimen with our cool pack.
Example of collection procedures from Copan Diagnostics
Standard Diagnostic Lab Testing For PUI or Persons with Confirmed COVID-19
Primex will perform standard diagnostics testing (non-COVID-19) for PUI and for confirmed COVID-19 patients. Specimens should be labeled that the patient is PUI or has COVID-19 so it can be appropriately tested per CDC biosafety laboratory guidelines.
Respiratory specimens collected at physician offices, clinics or hospital settings may be forwarded to Primex in the usual courier pick up manner.
According to the CDC, clinical laboratories may perform testing on non-respiratory tract specimens (e.g. blood, serum, urine) of suspected COVID-19 patients provided that they follow standard laboratory practices and precautions.