General Information
In which section of the PI/IFU are we most likely to find the correct way of interpreting results?
Interpretation of Results/Result Interpretation
What is the correct Storage of the Kit and in which section of the IFU can I find it?
Kit should be stored at 2-30C. (Higher temperatures up to 55C for a limited period of time, up to 48 accumulated hours). It can be found in Precaution/Kit Storage and Stability.
What is the name of the section in which we can find the following statement: "Prior to testing, mix the blood by gentle inversion several times, do not freeze or heat whole blood specimens."
Specimen Collection and Preparation (For venous whole blood:)
What is the name of the segment that details what is included and what not is included in the kit of the product?
Materials
In which section of the IFU is the information for the principle of the test: The Panbio is an immunochromatographic test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2.
Principle
What is the name of the segment in which we can find these directions:
• Start the timer. As the test begins to work, you will see purple color move across the result window in the center of the test device.
• Wait for 15 minutes and read the results. Do not read results after 20 minutes
Test Procedure
In which segment we are most likely to find what the product is for or what the product should be used for?
Intended Use
For Serum, we should collect whole blood into any collection tube by venipuncture and then centrifuge the blood to get serum specimen. True or False.
False. For Serum, we should collect whole blood into collection tube not containing anticoagulants by venipuncture, leave to settle for 30 minutes to allow for blood coagulation and then centrifuge the blood to get serum specimen.
Where can we find this statement and what are the three points in which this can happen?
• Positive test results do not rule out co-infections with other pathogens. A negative result of this reagent can be caused by:
Limitations of Procedure:
• improper sample collection, improper sample transfer or handing, the virus titer in the sample is too low.
• the level of SARS-CoV-2 antibodies is below the detection limit of the test.
• variations in viral genes may cause changes in antibody determinants.
Precaution/Kit Storage and Stability or Storage and Stability
Where can we find the following statement: "The test will show negative results under the following conditions: The titer of the novel coronavirus antibodies in the sample is lower than the minimum detection limit of the test".
Limitation
Which section describes the clinical cases that were made in order to gather results and sensitivity and specificity for this test device?
What is the name of the section of the PI/IFU in which we might find information on the control line for each test and that states that this visible control line confirms that the lateral flow of the test is successful?
Quality Control
In this section, we are to find other medical conditions or potentially interfering substances that did not affect the performance of the Panbio; conditions such as:
HAMA, Antinuclear antibody, Rheumatoid Factor, Influenza A and B IgG; substances such as ascorbic acid,hemoglobin, bilirubin, oxalic acid, human serum albumin.
Name three positive specimens from patients that were investigated with BasePoint Covid-19 IgG/IgM and that showed no cross reactivity:
Parainfluenza virus antibody, Influenza A antibody, Influenza B antibody, Chlamydia pneumonia antibody..etc
(Section Performance Characeristics, B Cross Reactivity)