BIOCREDIT Covid-19 IgG+IgM Duo

• ISO13485:2016 Cer­ti­fied
• CE, EC, REP, IVD
• To be used by health­ca­re centres
• For export que­ries plea­se con­ta­ct us

BIOCREDIT COVID-19 lgG/lgM Manual
ManualAntiGen.pdf
PDF-Docu­ment [437.1 KB]

CE Doku­ment COVID-19 lgG lgM
CE DoC_BIOCREDIT COVID-19 IgG+IgM Duo.pdf
PDF-Docu­ment [12.6 KB]

EU Pro­dukt Zer­ti­fi­kat COVID-19 lgG/lgM Duo
Rapi­GEN Cer­ti­fi­ca­te of EU pro­duct notification.pdf
PDF-Docu­ment [382.0 KB]

Rapi­GEN, Inc., South Korea, has deve­lo­ped one of the first immu­no­as­says for the dia­gno­sis of COVID-19 infection.

The BIOCREDIT COVID-19 IgG+ IgM DUO One Step Rapid Test is a late­ral flow immu­no­as­say for the simul­ta­ne­ous detec­tion and dif­fe­ren­tia­ti­on of IgG and IgM anti-COVID-19 in who­le human blood, serum or plasma.

It is inten­ded to be used by pro­fes­sio­nals as a screen test and as a sup­ple­ment in the dia­gno­sis of COVID-19 virus infection.

The BIOCREDIT COVID-19 IgG+IgM DUO One Step Rapid Test has been eva­lua­ted and com­pa­red to a gold stan­dard test using cli­ni­cal sam­ples. Results show a degree of con­cordance of >90%.

Descrip­ti­on

BIOCREDIT Coro­na­vi­rus Onme Step Rapid Test Kit COVID-19 anti­bo­dy IgG + IgM DUO– Pack 25 test

Bio­credit Covid-19 One Step Rapid Test lgG+LgM DUO has deve­lo­ped one of the first immu­no­as­says for the dia­gno­sis of COVID-19 infection.

This test detects both the ear­ly mar­ker and the late mar­ker, IgM/IgG anti­bo­dies in who­le blood samples.

Can be used in sym­pto­ma­tic or asym­pto­ma­tic patients.

Requi­res

• Works with who­le blood, serum or plasma
• Detects IgM and IgG antibodies
• Vali­da­ted using PCR

Fast

• 10 minu­tes per test
• Intui­ti­ve visu­al interptretation
• No spe­cial labo­ra­to­ry equip­ment needed
• No sam­ple trans­port nee­ded, may be per­for­med in situ by health­ca­re professionals.

App­li­ca­ti­ons of Bio­credit Coro­na­vi­rus Test Kit COVID-19 anti­bo­dy IgG+IgM DUO

• Gene­ral popu­la­ti­on screening
• Allows rapid exami­na­ti­on and diagnosis
• Desi­gned for health­ca­re pro­fes­sio­nals: Hos­pi­tals, medi­cal, phar­maci­es, offices, labo­ra­to­ries, Doc­tors, etc.
• Can detect car­ri­ers that are asymptomatic
• It can deter­mi­ne whe­ther the pati­ent was recent­ly affec­ted by the virus, even if the virus is no lon­ger present

Main app­li­ca­ti­ons of anti­bo­dy detec­tion during COVID-19:

• Pati­ents who go to the emer­gen­cy room with more than seven days from the onset of symptoms.
• In cases with repeated­ly nega­ti­ve PCR whe­re sym­ptoms have clear­ly star­ted several days befo­re. That is, to con­firm an infec­tion when the­re is a sus­pi­ci­on of a fal­se PCR negative.
• Detec­tion of anti­bo­dies in health care per­son­nel that would help iden­ti­fy tho­se who are alrea­dy immu­ne (IgGs pre­sence) and can return to work to care for infec­ted pati­ents mini­mi­zing the risk of virus spread to col­leagues and other patients.
• To under­stand the epi­de­mio­lo­gy of COVID-19, it also allows to know the role that asym­pto­ma­tic infec­tions could have played.
• Defi­ne pre­vious expo­sure and iden­ti­fy high­ly reac­ti­ve human donors for hyperim­mu­ne serum genera­ti­on as a the­ra­peu­tic approach.
• For rese­arch work (such as pos­si­ble plas­ma cli­ni­cal tri­als of immu­ni­zed patients.)
• For vac­ci­ne evaluation.

Assay Pro­ce­du­re                                           

Inter­pre­ta­ti­on of Results

A total of three detec­tion lines are pos­si­ble, the con­trol line © appears when the sam­ple is correct.

1 | IgG and IgM Positive:

The colo­red line in the con­trol line regi­on © appears and two colo­red lines should appe­ar in test line regi­ons G and M (G and M). The color inten­si­ties of the lines do not have to match. The result is posi­ti­ve for IgG & IgM anti­bo­dies and is indi­ca­ti­ve of secon­da­ry COVID-19 infection.

2 | IgG Positive:

The colo­red line in the con­trol line regi­on © appears and a colo­red line appears in test line regi­on G (G). The result is posi­ti­ve for COVID-19 spe­ci­fic-IgG and is pro­bab­ly indi­ca­ti­ve of secon­da­ry COVID-19 infection.

3 | IgM Positive:

The colo­red line in the con­trol line regi­on © appears and a colo­red line appears in test line regi­on M (M). The result is posi­ti­ve for COVID-19 virus spe­ci­fic-IgM anti­bo­dies and is indi­ca­ti­ve of pri­ma­ry COVID-19 infection.

4 | Nega­ti­ve result:

One red line „C“

IgM appears first after infec­tion with the virus and then IgG in the midd­le and late sta­ges of infection

IgM/IgG anti­bo­dy test can deter­mi­ne if a pati­ent is infec­ted “recent­ly 2019-nCoV”

It is wide­ly known that IgM pro­vi­des the first line of defen­se during viral infec­tions, fol­lo­wed by adap­ti­on genera­ti­on, high IgG affi­ni­ty respon­se for long-term immu­ni­ty and immu­ne memory.

The­re­fo­re, the test of COVID-19 IgM and IgG anti­bo­dies is an effec­ti­ve method for rapid dia­gno­sis of COVID-19 infection.

In addi­ti­on, detec­tion of IgM anti­bo­dies against COVID-19 tends to indi­ca­te recent expo­sure to COVID-19, while detec­tion of COVID-19 IgG anti­bo­dies indi­ca­tes a later sta­ge of infec­tion. Thus, this com­bi­ned anti­bo­dy test could also pro­vi­de infor­ma­ti­on on the sta­ge of infection.

KIT CONTENTS

• Indi­vi­du­al­ly packa­ged test units X the num­ber of kit tests: 25
• Dis­po­sable pipet­tes X the num­ber of kit tests: 25
• Buf­fer (two con­tai­ner with suf­fi­ci­ent con­tent for Kit units: 25)
• Inst­ruc­tions gui­de in Eng­lish and German

Manu­fac­tu­rer: Rapi­GEN Inc., 2F, 25, Heungan-dae­ro, Gun­po-si, Gye­ong­gi-do 15809, Repu­blic of Korea
Euro­pean Repre­sen­ta­ti­ve: MT Pro­medt Con­sul­ting GmbH, Alten­hof­stras­se. 80, 66386 St. Ing­bert, Germany
Dis­tri­bu­ti­on Phar­maci­es: Weko Phar­ma GmbH, Hoch­wald­blick 3–4, 54331 Pellingen