INTENDED USE:

The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum or plasma (sodium EDTA). The Assure COVID-19 IgG/IgM  Rapid  Test  Device  is  intended  for  use  as  an  aid  in  identifying  individuals  with  an  adaptive  immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Assure COVID-19 IgG/IgM Rapid Test Device should not be used to diagnose acute SARS-CoV-2 infection.  Testing  is  limited  to  laboratories  certified  under  the  Clinical  Laboratory  Improvement Amendments (CLIA)  of  1988,  42  U.S.C.  §263a,  that  meet  requirements  to  perform  moderate  or  high  complexity tests.   Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2 are  generally  detectable  in  blood  several  days  after  initial  infection,  although  the  duration  of  time  antibodies  are  present  post-infection  is  not  well  characterized.  Individuals  may  have  detectable  virus  present for several weeks following seroconversion. Laboratories  within  the  United  States  and  its  territories  are  required  to  report  all  positive  results  to  the  appropriate public health authorities. The  sensitivity  of  Assure  COVID-19  IgG/IgM  Rapid  Test  Device  early  after  infection  is  unknown.  Negative  results  do  not  preclude  acute  SARS-CoV-2  infection.  If  acute  infection  is  suspected,  direct  testing for SARS-CoV-2 is necessary. False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay. The  Assure  COVID-19  IgG/IgM  Rapid  Test  Device  is  only  for  use  under  the  Food  and  Drug  Administration’s Emergency Use Authorization. 

SUMMARY AND EXPLANATION:

Coronaviruses  are  a  large  family  of  viruses  that  are  common  in  many  different  species  of  animals,  including camels, cattle, cats, and bats. The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause severe respiratory syndrome in humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43 and HKU1) induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause severe infections in infants, young children and elderly individuals1,2,3. COVID-19 is the disease associated with SARS-CoV-2, which was identified in China at the end of 2019. Coronaviruses cause respiratory and intestinal infections in animals and humans1. The  virus  is  transmitted  mainly  via  respiratory  droplets  that  people  sneeze,  cough,  or  exhale.  The incubation period for COVID-19 is currently estimated at between two and 14 days. Common symptoms of COVID-19 infection include fever, cough and respiratory symptoms such as shortness of breath and breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the death of the patient. People with existing chronic conditions seem to be more vulnerable to severe illness.Detection of IgM indicates recent infection and can be used for early diagnosis of infection. IgG antibodies gradually  appear  and  increase  in  the  late  stage  of  infection,  and  the Assure  COVID-19 IgG/IgM  Rapid  Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgMantibody. It will provide a presumptive diagnosis of COVID-19. 

PRINCIPLE:

The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow immunochromatographic assay for the  detection  of  SARS-CoV-2  antibodies  in  venous  whole  blood,  serum  or  plasma.  This  test  uses  anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip. The conjugate pad contains recombinant SARS-CoV-2 antigen (antigen is recombinant Nucleocapsid Protein and Spike Protein (S1)) conjugated with colloid gold. During testing, the specimen binds with SARS-CoV-2 antigen-  conjugated gold colloid coated particles in the test cassette. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies  if  present,  will  bind  to  COVID-19  conjugates  making  antigen  antibodies  complex.  This  complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is trapped forming a red line which confirm a reactive test result. Absence of a red line in the test region indicates a non-reactive test result.To serve as a procedural control, a red line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

REAGENTS AND MATERIALS: 

Materials Provided：   

•Individually packed test devices•Disposable pipettes•Sterile safety lancet•Negative control•Buffer •Package insert•Alcohol Prep pad•Positivecontrol

External Negative and Positive Control：

Negative controls are lyophilized human serum samples and positive controls are lyophilized IgG and IgM against  SARS-CoV-2.  Two  negative  control  vials  are  supplied.  Reconstitute  each  negative  control  vial  with 30 μL purified water. Transfer one reconstituted 30 μL negative control to the positive control vial to  make  ready-to-use  positive  control.   Controls  can  be  used  like  a  serum  sample.  Store  reconstituted  controls at 4oC.   

Materials Required but Not Provided：

•Clock, timer or stopwatch•Specimen collection container

WARNING AND PRECAUTIONS:

For use under an Emergency Use Authorization Only.•For in vitro Diagnostic Use Only.•This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.•This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.•Read the Package Insert prior to use. Directions should be read and followed carefully. •Do not use kit or components beyond the expiration date.•The device contains material of animal origin and should be handled as a potential biohazard. Do not use if pouch is damaged or open. •Test  devices  are  packaged  in  foil  pouches  that  exclude  moisture  during  storage.  Inspect  each  foil  pouch before opening. Do not use devices that have holes in the foil or where the pouch has not been completely sealed. Erroneous result may occur if test reagents or components are improperly stored.•Do not use the Buffer if it is discolored or turbid. Discoloration or turbidity may be a sign of microbial contamination. •All  patient  specimens  should  be  handled  and  discarded  as  if  they  are  biologically  hazardous.  All  specimens must be mixed thoroughly before testing to ensure a representative sample prior to testing.•Failure  to  bring  specimens  and  reagents  to  room  temperature  before  testing  may  decrease  assay  sensitivity.  Inaccurate  or  inappropriate  specimen  collection,  storage,  and  transport  may  yield  false  negative test results.•Avoid skin contact with buffer containing sodium azide which is a skin irritant.•If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria  recommended  by  public  health  authorities,  specimens  should  be  collected  with  appropriate  infection control precautions and sent to state or local health departments for testing. •Humidity and temperature can adversely affect results.

STORAGE AND STABILITY:

Store the Assure COVID-19 IgG/IgM Rapid Test Device at 2~30°Cwhen not in use.•DO NOT FREEZE. •Kit contents are stable until the expiration dates marked on their outer packaging and containers.•Perform testing immediately after specimen collection. Serum and plasma specimens may be stored at 2-8°C  for  up  to  7 days.  For  long  term  storage,  serum  or  plasma  specimens  should  be  kept  below  -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days after collection. Do not freeze whole blood specimens.•Containers containing anticoagulants such as sodium EDTA, should be used for whole blood storage.•Bring  specimens  to  room  temperature  prior  to  testing.  Frozen  serum  or  plasma  specimens  must  be  completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.•If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agent