COVID 19 IgGIgM Rapid Test Device - COVID-19 IgG/IgM Rapid Test Device

INTEND­ED USE

COVID-19 IgG/​IgM Rapid Test Device is a rapid chro­mato­graph­ic immunoas­say for the qual­i­ta­tive detec­tion of IgG & IgM anti­body of COVID-19 IgM in human whole blood , serum, or plas­ma as an aid in the diag­no­sis of COVID-19 infections.

SUM­MA­RY

Coro­n­avirus (CoV) belongs to the genus Nestovirus, Coro­n­aviri­dae, and is divid­ed into three gen­era : α, β, and γ. The genus α and β are only path­o­gen­ic to mam­mals. The genus γ main­ly caus­es bird infec­tions. CoV is main­ly trans­mit­ted through direct con­tact with secre­tions or through aerosols and droplets. There is also evi­dence that it can be trans­mit­ted through the fecal-oral route.

So far, there are 7 types of human coro­n­avirus (HCoV) that cause human res­pi­ra­to­ry dis­eases : HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and COVID-19, Is an impor­tant pathogen of human res­pi­ra­to­ry infec­tions. Among them, COVID-19 was dis­cov­ered due to Wuhan virus pneu­mo­nia cas­es in 2019. The clin­i­cal man­i­fes­ta­tions are sys­temic symp­toms such as fever and fatigue, accom­pa­nied by dry cough and dys­p­nea, etc., which can rapid­ly devel­op into severe pneu­mo­nia, res­pi­ra­to­ry fail­ure, and acute breath­ing. Dis­tress syn­drome, sep­tic shock, mul­ti­ple organ fail­ure, severe acid-base metab­o­lism dis­or­ders, etc. are even life-threatening.

PRIN­CI­PLE

This kit uses immunochro­matog­ra­phy. The test card con­tains : 1) col­loidal gold-labeled recom­bi­nant new coro­n­avirus anti­gen and qual­i­ty con­trol anti­body gold mark­ers ; 2) two detec­tion lines (G and M lines) and one qual­i­ty Con­trol line (C line) of nitro­cel­lu­lose mem­brane. The M line is immo­bi­lized with a mon­o­clon­al anti-human IgM anti­body for detect­ing a new coro­n­avirus IgM anti­body ; the G line is immo­bi­lized with a reagent for detect­ing a new coro­n­avirus IgG anti­body ; and the C line is immo­bi­lized with a qual­i­ty con­trol anti­body.

When an appro­pri­ate amount of the test sam­ple is added to the sam­ple hole of the test card, the sam­ple will move for­ward along the test card under the action of the cap­il­lary. If the sam­ple con­tains an IgM anti­body, the anti­body will bind to the col­loidal gold-labeled new coro­n­avirus anti­gen. The immune com­plex will be cap­tured by the anti-human IgM anti­body immo­bi­lized on the mem­brane to form a pur­­ple-red M line, show­ing that the new coro­n­avirus IgM anti­body is pos­i­tive.

If the sam­ple con­tains an IgG anti­body, the anti­body will bind to the col­loidal gold-labeled new coro­n­avirus anti­gen, and the immune com­plex will be cap­tured by the reagent immo­bi­lized on the mem­brane to form a pur­­ple-red G line, indi­cat­ing that the new coro­n­avirus IgG anti­body is pos­i­tive.

If the test lines G and M are not col­ored, a neg­a­tive result is dis­played. The test card also con­tains a qual­i­ty con­trol line C. The fuch­sia qual­i­ty con­trol line C should appear regard­less of whether a test line appears. The qual­i­ty con­trol line is a col­or band of the qual­i­ty con­trol anti­body immune com­plex. If the qual­i­ty con­trol line C does not appear, the test result is invalid, and the sam­ple needs to be test­ed again with anoth­er test card.

REAGENTS

The test con­tains COVID-19 virus enve­lope pro­tein par­ti­cles and anti-human IgG,anti-human IgM anti­body con­ju­gat­ed gold par­ti­cles coat­ed on the membrane.

PRE­CAU­TIONS

  • For pro­fes­sion­al in vit­ro diag­nos­tic use only. Do not use the kit beyond the expi­ra­tion date.
  • Do not eat, drink or smoke in the area where the spec­i­mens or kits are handled.
  • Do not use the test if the pouch is damaged.
  • Han­dle all spec­i­mens as if they con­tain infec­tious agents. Observe estab­lished pre­cau­tions against micro­bi­o­log­i­cal haz­ards through­out test­ing and fol­low the stan­dard pro­ce­dures for prop­er dis­pos­al of specimens.
  • Wear pro­tec­tive cloth­ing such as lab­o­ra­to­ry coats, dis­pos­able gloves and eye pro­tec­tion when spec­i­mens are being tested.
  • The used test should be dis­card­ed accord­ing to local regulations.

STOR­AGE AND STA­BIL­I­TY

  • The orig­i­nal pack­ag­ing should be stored at 4~ 30 ℃, to avoid light, keep dry.
  • The test device is sta­ble through the expi­ra­tion date print­ed on the sealed pouch. The test device must remain in the sealed pouch until use​.DO NOT FREEZE
  • Do not use beyond the expi­ra­tion date, espe­cial­ly at tem­per­a­tures above 30℃ or under high humid­i­ty con­di­tions, should be used imme­di­ate­ly once it is opened.

SPEC­I­MEN COL­LEC­TION AND PREPA­RA­TION

  • The COVID-19 IgG/​IgM Rapid Test Device is intend­ed for use with human whole blood, serum or plas­ma spec­i­mens only.
  • Only clear, non-hemolyzed spec­i­mens are rec­om­mend­ed for use with this test. Serum or plas­ma should be sep­a­rat­ed as soon as pos­si­ble to avoid hemolysis.
  • Per­form test­ing imme­di­ate­ly after spec­i­men col­lec­tion. Do not leave spec­i­mens at room tem­per­a­ture for pro­longed peri­ods. Serum and plas­ma spec­i­mens may be stored at 2-8°C for up to 3 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 2 days after col­lec­tion. Do not freeze whole blood spec­i­mens. Whole blood col­lect­ed by fin­ger­stick should be test­ed immediately.
  • Con­tain­ers con­tain­ing anti­co­ag­u­lants such as EDTA, cit­rate, or heparin should be used for whole blood storage.
  • Bring spec­i­mens to room tem­per­a­ture pri­or to test­ing. Frozen 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 agents.
  • Icteric, lipemic, hemolyzed, heat treat­ed and con­t­a­m­i­nat­ed sera may cause erro­neous results.

MATE­RI­ALS

Mate­ri­als Provided 

Test DevicesBuffer
Dis­pos­able plas­tic pipettePack­age insert

Mate­ri­als Required But Not Provided

Spec­i­men col­lec­tion containersCen­trifuge (for plas­ma only)
MicropipetteTimer
Lancets (for fin­ger stick whole blood only)

DIREC­TIONS FOR USE

  • Allow the test device, spec­i­men, buffer, and/​or con­trols to reach room tem­per­a­ture (15-30°C) pri­or to testing.
  • Bring the pouch to room tem­per­a­ture before open­ing. Remove the test device from the sealed pouch and use it as soon as possible.
  • Place the test device on a clean and lev­el sur­face.
    For Serum or Plas­ma Spec­i­mens :
    Using the pro­vid­ed 10uL dis­pos­able pipette, draw the spec­i­men up to the Fill Line, and trans­fer 10ul serum/​plasma to the spec­i­men well of the test device, then add 2 drops of buffer and start the timer.
    For Whole Blood (Venipuncture/​Fingerstick) Spec­i­mens :
    Using the pro­vid­ed 10uL dis­pos­able pipette, and trans­fer 1 drop of whole blood (approximately20µL) to the spec­i­men well of the test device, then add 2 drops of buffer and start the timer.
    Note : Spec­i­mens can also be applied using a micropipette.
  • Wait for the col­ored line(s) to appear. Read results at 10 min­utes. Do not inter­pret the result after 15 minutes.
DIRECTIONS FOR USE - COVID-19 IgG/IgM Rapid Test Device
DIREC­TIONS FOR USE

INTER­PRE­TA­TION OF RESULTS

IgG POS­I­TIVE : *The col­ored line in the con­trol line region (C) appears and a col­ored line appears in test line region IgG. The result is pos­i­tive for COVID-19-IgG anti­bod­ies.
IgM POS­I­TIVE : *The col­ored line in the con­trol line region (C) appears and a col­ored line appears in test line region IgM. The result is pos­i­tive for COVID-19-IgM anti­bod­ies and is indica­tive of pri­ma­ry COVID-19 infec­tion.
IgG AND IgM POS­I­TIVE : *The col­ored line in the con­trol line region (C) appears and two-col­ored lines should appear in test line regions IgG and IgM. The col­or inten­si­ties of the lines do not have to match. The result is pos­i­tive for IgG & IgM anti­bod­ies.
*NOTE : The inten­si­ty of the col­or in the test line region(s) IgG and/​or IgM will vary depend­ing on the con­cen­tra­tion of COVID-19 anti­bod­ies in the spec­i­men. There­fore, any shade of col­or in the test line region(s) IgG and/​or IgM should be con­sid­ered pos­i­tive.
NEG­A­TIVE : The col­ored line in the con­trol line region (C) appears. No line appears in test line regions IgG or IgM.
INVALID : There is no line appear in the c region.
Insuf­fi­cient buffer vol­ume or incor­rect pro­ce­dur­al tech­niques are the most like­ly rea­sons for con­trol line fail­ure. Review the pro­ce­dure and repeat the pro­ce­dure with a new test device. If the prob­lem per­sists, dis­con­tin­ue using the test kit imme­di­ate­ly and con­tact your local distributor.

QUAL­I­TY CON­TROL

Inter­nal pro­ce­dur­al con­trols are includ­ed in the test. A col­or line appear­ing in the con­trol region (C) is an inter­nal pos­i­tive pro­ce­dur­al con­trol. It con­firms suf­fi­cient spec­i­men vol­ume and cor­rect pro­ce­dur­al tech­nique.

Con­trol stan­dards are not sup­plied with this kit ; how­ev­er, it is rec­om­mend­ed that pos­i­tive and neg­a­tive con­trols be test­ed as a good lab­o­ra­to­ry prac­tice to con­firm the test pro­ce­dure and to ver­i­fy prop­er test performance.

PER­FOR­MANCE CHAR­AC­TER­IS­TICS

For Healthy Per­sons :
The 2019-nCOV IgG/​IgM Rapid Test Device was com­pared with RT-PCR Reagent using clin­i­cal spec­i­mens from 100 healthy persons.

ResultCOVID-19 IgG Rapid COVID-19 IgM RapidRT-PCR
Pos­i­tive000
Neg­a­tive100100100
Accu­ra­cy100%100%100%

For Iden­ti­fied Per­sons :
The 2019-nCOV IgG/​IgM Rapid Test Device was com­pared with RT-PCR Reagent using clin­i­cal spec­i­mens from 200 2019-nCOV iden­ti­fied patients.

ResultCOVID-19 IgG RapidCOVID-19 IgM RapidRT-PCR
Pos­i­tive192181200
Neg­a­tive8190
Accu­ra­cy96%90.5%100%

For sus­pectable per­sons :
The 2019-nCOV IgG/​IgM Rapid Test Device was com­pared with RT-PCR Reagent using clin­i­cal spec­i­mens from 200 sus­pectable 2019-nCOV patients, the results of RT-PCR are all negative.

Result COVID-19 IgG Rapid COVID-19 IgM Rapid RT-PCR
Pos­i­tive1491400
Neg­a­tive5160200
Accu­ra­cy74.5%70%0%
Notice : In our clin­i­cal report, all the data sam­ples used in the file are real clin­i­cal ones. Our prod­uct has a high year-on-year detec­tion rate in the mar­ket. In Chi­na, we have test­ed near­ly 800 sam­ples and only one false pos­i­tive appeared. 

SYM­BOLS

Sym­bolMean­ingSym­bolMean­ing
In vitro diagnostic - COVID-19 IgG/IgM Rapid Test DeviceIn vit­ro diag­nos­tic med­ical deviceStorage temperature limit - COVID-19 IgG/IgM Rapid Test DeviceStor­age tem­per­a­ture limit
Manufacturer - COVID-19 IgG/IgM Rapid Test DeviceMan­u­fac­tur­erAuthorized representative in the European Community - COVID-19 IgG/IgM Rapid Test DeviceAutho­rized rep­re­sen­ta­tive in the Euro­pean Community
Date of Manufacture - COVID-19 IgG/IgM Rapid Test DeviceDate of ManufactureUse by date - COVID-19 IgG/IgM Rapid Test DeviceUse by date
Do not reuse - COVID-19 IgG/IgM Rapid Test DeviceDo not reuseConsult instruction for use - COVID-19 IgG/IgM Rapid Test DeviceCon­sult instruc­tion for use
Batch code - COVID-19 IgG/IgM Rapid Test DeviceBatch codeMeet the requirements of EC Directive 9879EC - COVID-19 IgG/IgM Rapid Test DeviceMeet the require­ments of EC Direc­tive 98/79/EC

This prod­uct is devel­oped by our R&D com­pa­ny Cam­ing Phar­ma­ceu­ti­cal Ltd (httpS://​www​.cam​ing​.com/), and here is the cor­re­spond­ing link https://​www​.cam​ing​.com/​c​o​v​i​d​-​1​9​-​i​g​g​-​i​g​m​-​r​a​p​i​d​-​t​e​s​t​-​d​e​v​i​ce/

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