QuickProfile™ SARS-CoV-2 Neutralizing Antibody Test is an immunochromatography based one step
in vitro test. The test is intended for professional and laboratory use as an aid in semi-quantitatively
monitoring human SARS-CoV-2 neutralizing antibodies in human fingerstick blood and serum
specimens after vaccination.
SUMMARY AND EXPLANATION
SARS-CoV-2 virus infects human cells through its binding to human ACE-2 receptor by its Receptor
Binding Domain (RBD) in Spike Protein (S Protein). Human antibodies against RBD either raised by
natural immunization through virus contact or by vaccination can block the binding of the virus to human
cell to prevent the infection. This type of antibodies is called SARS-CoV-2 Neutralizing Antibody. By
monitoring the level of SARS-CoV-2 Neutralizing Antibody, it provides the information of the efficacy of
QuickProfile™ SARS-CoV-2 Neutralizing Antibody Test is a rapid immunochromatographic assay that
utilizes recombinant SARS-CoV-2 S1/RBD protein as the conjugate detector and mouse anti-human
IgG for membrane capture to detect SARS-CoV-2 neutralizing antibodies. When specimen is added to
sample port of the device, a colored band will be visible at the test line zone if SARS-CoV-2 neutralizing
antibodies are present. The color intensity is dependent on the concentration of SARS-CoV-2
neutralizing antibodies in the sample. On the other hand, a light color band will always appear at the
reference line zone. This reference band serves as a reference of set antibody titer in the sample. In
addition to the test line and reference line, there is a clear color band will always appear on the control
line zone to indicate that the test has been correctly performed and the test device functions properly.
Read the package insert carefully prior to testing the kit and follow the instructions to obtain accurate results.
1. For in vitro diagnostic use.
2. Do not use the kit contents beyond the expiration date printed on the outside of the box.
3. Do not interchange or mix different lots of components.
4. Disregard test results beyond the specified time (15 minutes).
5. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples
and used kit contents.
6. Use of protective tools are recommended when handling patient samples.
7. Dispose of containers and used contents in accordance with Federal, State and Local requirements.
8. Do not reuse kit components.
9. The test device must remain sealed in the protective foil pouch until use.
10. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test
11. Seek specific training or guidance if you are not experienced with specimen collection and handling
12. If infection with a novel SARS-CoV-2 virus is suspected based on current clinical and
epidemiological screening criteria recommended by public health authorities, specimens should be
collected with appropriate infection control precautions for novel virulent SARS-CoV-2 viruses and
sent to state or local health departments for testing. Viral culture should not be attempted in these
cases unless a BSL 3+ facility is available to receive and culture specimens.
STORAGE AND STABILITY
1. Store the test device at 4 to 30ºC in the original sealed pouch. Do Not Freeze.
2. Kit contents are stable until the expiration date printed on the outer box based on the proper
3. The test device should remain in its original sealed pouch until use.
- QuickProfile™ SARS-CoV-2 Neutralizing Antibody Test Card (25 devices)
Each device houses a strip incorporated with mouse anti-human IgG antibody
monoclonal antibody and recombinant SARS-CoV-2 S1/RBD protein, and is
packed in an individual foil pouch.
- Ampoule Sample buffer: Solution contains salt and detergent (25 Ampoules – if provided in Ampoule mode)
- Buffer Sample buffer: Solution contains salt and detergent (1 bottle if provided in bottle mode)
- 10 μL capillary sample pipet
- Instructions for Use (1 copy)
MATERIALS REQUIRED BUT NOT SUPPLIED
1. Safety lancet
2. Serum: Vacutainer tube, or other appropriate tube, without anticoagulant
3. Volumetric pipettor
4. Timer or clock
5. Personal Protective Equipment
1. The control band is an internal reagent and procedural control. It will appear if the test has been
performed correctly and the reagents are reactive.
2. Good laboratory practice recommends the daily use of control materials to validate the reliability of
the device. Control materials, which are not provided with this test kit, may be commercially
SPECIMEN COLLECTION AND PREPARATION
1. The serum or fingerstick blood should be collected under standard laboratory conditions.
2. Fingerstick sample should be tested immediately after collection. If the assay is not performed
immediately, serum sample can be frozen until the test can be performed. Frozen samples should
be thawed and brought to room temperature before proceeding. The sample performs best when
tested immediately after collection.
3. Sodium azide can be added as a preservative up to 0.1% without affecting the test results.