Intended use

The PocRoc®SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (TRFIA) is used Time Resolved Fluorescence Immunochromatographic Assays (TRFIA) technology to qualitative detection of SARS-CoV-2 neutralizing antibodies in human finger stick blood, serum, plasma or whole blood samples in vitro. SARS-CoV-2 Neutralizing antibody is an important marker for assessing the effectiveness of the SARS-CoV-2 vaccines. The reagent is for neutralizing antibody detection in samples from individuals after vaccine injection or recovered from SARS-CoV-2. PocRoc®SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (TRFIA) has great significance for the development of SARS-CoV-2 vaccines, evaluation of effectiveness, and evaluation of neutralizing antibody levels in human bodies.

For Medical Professional Use Only!

Product Information

Storage Conditions

All reagents are ready to use as supplied. Unopened reagent kits are stable at 4°C ~30°C for 24 months tentatively. It should be used within 1 hour once the pouch is opened. Do not freeze the kit or expose the kit above 37°C during storage.

Samples collection and test procedure

1、Sample should be finger stick blood，human serum, plasma or whole blood, other body fluid and samples may cause incorrect or inaccurate results.

2、Venous blood should be collected under sterile condition at any time of a day.

3、It is recommended to use serum or plasma for better results.

4、Heparin, sodium citrate and EDTA can be used as anticoagulant for plasma and whole blood sample.

5、Serum, plasma or whole blood sample should be tested within 4 hours after blood collection in room temperature. If testing is delayed, serum and plasma may be stored up to 5 days at 2-8°C or stored for 6 months at -20°C before testing (whole blood sample may be stored up to 3 days at 2-8°C). Do not heat the samples and the hemolyzed samples couldn’t be used as test samples.

6、Bring all samples to room temperature before use. Refrigerated or frozen samples should be balanced at room temperature before testing. Avoid multiple freeze-thaw cycles.

Test Procedure

1、Do not open the sealing strip until you are ready to perform a test, and the single-use test is suggested to be used under low environment humidity (RH≤70%) within 1 hour.

2、Allow all the components of the kit and specimens to reach room temperature between 18°C~26°C prior to testing.

3、Take out the test card and place it on a clean dry surface.

4、Identify the test card for each specimen.

5、Use dropper to deliver one drop (~30μL) whole blood samples into the sample well on the test card, followed by one drops (~30μL) of sample buffer.

6、After 15 minutes of reaction, the data can be readed and printed out using TRFIA analyzer (For detailed information refer to the operating instructions for TRFIA analyzer).