Oswald’s Pharmacy has switched from the Assure Tech POC Covid-19 IgG/IgM Rapid Test to the Assure Tech POC Covid-19 IgG/IgM Rapid Test Device for two main reasons: accuracy for COVID-19 variations and ease of testing for our technicians. We want our patients and customers to know that all of our COVID-19 Antibody tests are being handled by CLIA lab-certified technicians using one of the most accurate COVID-19 Tests currently available.
How the Assure Tech POC Covid-19 IgG/IgM Rapid Testing Process Works at Oswald’s
1) Patient arrives for the appointment and is given a clipboard with information to fill out. Pens and clipboards are sanitized between patient use.
2) Patient enters the laboratory and sits in the lab chair while the phlebotomist prepares the test cassette. A motorized fan operates all day to ensure proper airflow in the lab.
4) Once a finger for a prick test is chosen, the phlebotomist will clean the area with alcohol, then use the newly-opened, sanitized finger prick test.
5) The phlebotomist takes the sample and places a bandage on the puncture site.
6) The phlebotomist analyzes the blood sample.
7) While the patient waits for results, the phlebotomist will sanitize the lab chair, table, and supplies the patient used to fill out their information forms.
9) The phlebotomist will then share test results with the patient.
11) The phlebotomist will print an itemized receipt containing information and test results for the patient’s personal medical use
Book Your COVID-19 Antibody Test Today
FDA Information on the Assure Tech POC Covid-19 IgG/IgM Rapid Test Device
Developer: Assure Tech
Test: COVID-19 IgG/IgM Rapid Test Device
Technology: Lateral Flow Chromatographic
Target: Spike Protein
| Antibody | Performance Measure | Estimate of Performance | 95% Confidence Interval |
| IgM+ | Sensitivity | 100% (30/30) | (88.7%; 100%) |
| IgM- | Specificity | 98.8% (79/80) | (93.3%; 98.8%) |
| IgG+ | Sensitivity | 90% (27/30) | (74.4%; 96.5%) |
| IgG- | Specificity | 100% (80/80) | (95.4%; 100%) |
| Combined | Sensitivity | 100% (30/30) | (88.7%; 100%) |
| Combined | Specificity | 99.8% (79/80) | (93.3%; 98.8%) |
| Combined | PPV at prevalence = 5% | 80.8% | (40.9%; 96%) |
| Combined | NPV at prevalence = 5% | 100% | (99.4%; 100%) |
COVID-19 Antibody Testing at Oswald’s
We currently offer COVID-19 Antibody testing on a weekly schedule. Click here for availability and online signups. If you have any questions about the tests, results, or any part of the COVID-19 Antibody testing process, please talk to one of our lab technicians or send us an email.
Book Your COVID-19 Antibody Test Today
More from the Oswald’s Pharmacy Lab Director:
“As with any technology, laboratory tests can improve with time. Now that we are into our 3rd year of living with COVID infections, we thought that it would be wise to see if there are new tests available to aid Oswald’s Pharmacy in its efforts to provide comprehensive COVID testing. Indeed, there is a new test for covid antibodies, the Assure Tech COVID-19 IgG/IgM, which has great performance characteristics. It does not require venipuncture, rather a finger-stick blood sample, so it is less invasive while performing equally as well as the Assure Tech test did. We are confident that this test will serve the needs of Oswald’s Pharmacy clients well.”
Each month we review the following lab conditions to ensure the accuracy of our COVID-19 antibody tests:
- Temperatures
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- Laboratory (e.g. room temperature)
- Reagent storage (e.g. refrigerator/freezer)
- Safety
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- Eyewash (is it checked regularly?).
- Records that staff have sufficient PPE available and that they are using it appropriately
- Quality Control
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- Are any external controls being run (e.g. with a new lot, new shipment)
- Any issues identified in quality control?
- Proficiency Testing
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- Did any occur that month?
Brian N. Kelly, Ph.D., DABCC, FAACC
Documentation:
Assure Tech POC Covid-19 IgG/IgM Rapid Test Device Fact Sheet for Recipients
Assure Tech POC Covid-19 IgG/IgM Rapid Test Device Fact Sheet for Healthcare Providers
Other COVID-19 Tests Available at Oswald’s
COVID-19 Vaccines. Doses and boosters for all available ages. Click here for more information and scheduling options.
Drive Up Rapid COVID-19 Antigen Test. Click here for more information and scheduling options.
48-Hour Drive Up PCR/Molecular COVID-19 Test. Click here for more information and scheduling options.
Further Reading from the FDA
