CorDx

COVID-19 S-RBD/NP Ab Test

COVID-19 S-RBD/NP Ab Test is used for qualitative detection of the NP antibody and S-RBD antibody of COVID-19 in human serum/plas- ma or whole blood. The test is COVID-19 antibody-positive population to assist diagnosis. People who have been infected with the COVID-19 or who have been injected with the inactivated

INTENDED USE

COVID-19 S-RBD/NP Ab Test is used for qualitative detection of the NP antibody and S-RBD antibody of COVID-19 in human serum/plas- ma or whole blood. The test is COVID-19 antibody-positive population to assist diagnosis. People who have been infected with the COVID-19 or who have been injected with the inactivated COVID-19 vaccine will have S-RBD antibody and NP antibody positive at the same time, and those who have been injected with mRNA vaccine or adenovirus vector vaccine will only be S-RBD antibody positive.The S-RBD antibody is the most important neutralizing antibody. The presence of the S-RBD antibody represents the human body’s ability to resist the COVID-19. COVID-19 S-RBD/NP Ab Test should not be used as the sole basis for diagnosis.

 

INTRODUCTION

CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. Evidence suggests transmission via fecal-oral route.7 kinds of HCoVs caused human ‘s respiratory diseas- es are found by now: HCoV-229E, HCoV-OC43,SARS-CoV,H- CoV-NL63,HCoV-HKU1, MERS-CoV and COVID-19 which are the serious pathogens for human’ s respiratory diseases. It’ s clinical manifestation are fever, enervate and systemic symptom, with dry cough, difficult breathing etc. and it may aggravate to severe pneumo- nia, respiratory failure, acute respiratory distress syndrome ,septic shock, multiple organ failure, severe acid-base metabolic disorders etc and even life threatening rapidly.

 

SPECIMEN PREPARATION

  1. The specimen is human serum/plasma and whole blood, including clinical anticoagulants (EDTA, heparin, sodium citrate) origin prepared serum or whole blood.
  2. Do the test immediately after specimen collection. Do not keep samples at room temperature for more than 24 hours. The speci- men could be stored at 2 to 8℃ up to 5 days if testing can ‘t be done immediate after specimen collection. The specimens could be frozen at -20℃ for longer storage. Avoid multiple freeze-thaw cycles.
  3. Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.The precipitate should be removed by centrifugation prior to the test if clearly visible particles existed in the specimen.
  4. Do not perform the test if specimen including massive lipid, hemo- lysis or turbidity against invalid test result.

 

TEST PROCEDURE

Read the instruction first prior to testing.Bring the pouched test to room temperature prior to testing. Do not open the pouch until ready to begin testing.

  1. Remove the test from the sealed pouch.Lay it on a flat, clean and dry surface.
  2. Using the provided pipette,add 1drop specimen to the sample well.
  3. Hold the buffer bottle vertically and add 2 drops (approximate 70μl) to sample wells.
  4. Read results within 10-15 minutes.

 

INTERPRETATION OF RESULTS

S-RBD & NP antibody Positive: Control line and T1 line & T2 line appear in the show window. S-RBD antibody Positive: Two colored lines appear,one is in T1 area and the other line is in Control area. NP antibody Positive: Two colored lines appear,one is in T2 area and the other line is in Control area. Negative: Only one line appears in Control area,No line appears in T1/T2 area. Invalid: If no line appears in the control area,the test results are invalid regardless of the presence or absence of line in the test area.The direction may not been followed correctly or the test may be deteriorated.It is recommended that repeat the test using a new device.If the problem persist,please stop to use the product and contact local distributor.