BIOCREDIT Covid-19 Ag

• EN ISO: 13485:2016
• CE, EC, REP, IVD
• Avail­ab­le for medi­cal Insti­tu­ti­ons in Euro­pe wit­hin 24–48 hours

CE Doku­ment COVID-19 Ag
CE DoC_BIOCREDIT COVID-19 Ag.pdf
PDF-Docu­ment [12.3 KB]

EU Pro­dukt Zer­ti­fi­kat COVID-19 Ag
Rapi­GEN Cer­ti­fi­ca­te of EU pro­duct notifi[…]
PDF-Docu­ment [382.0 KB]

BIOCREDIT COVID-19 Ag Gebrauchsanleitung
ManualAntiGen.pdf
PDF-Docu­ment [443 KB]

Descrip­ti­on

One Step SARS-CoV‑2 Anti­gen Rapid Test Bio­credit – 20 Pack test

BIOCREDIT COVID-19 Ag is a late­ral flow immu­no­chro­ma­to­gra­phic assay that adop­ted dual color sys­tem. The test con­tains col­lo­id gold con­ju­ga­te pad and a mem­bra­ne strip pre-coated with anti­bo­dies spe­ci­fic to SARS-CoV‑2 anti­gen on the test lines (T). If SARS-CoV‑2 anti­gen is pre­sent in the spe­ci­men, a visi­ble black band appears on the test lines (T) as anti­bo­dy-anti­gen-anti­bo­dy gold con­ju­ga­te com­plex forms. The con­trol line © is used for pro­ce­du­ral con­trol and should always appe­ar if the test is per­for­med cor­rect­ly. For the qua­li­ta­ti­ve detec­tion of SARS-CoV‑2 anti­gen from nasopha­ryn­ge­al swab spe­ci­men with results in just 5 minutes.

BIOCREDIT COVID-19 Ag has been eva­lua­ted with panel spe­ci­men by PCR. The results have shown Sen­si­ti­vi­ty levels of 92.0% and Spe­ci­fi­ci­ty of 98%.

The Rapid Bio­credit Anti­gen Test from Rapi­GEN, South Korea, offers a fast and reli­able solu­ti­on for detec­tion of SARS-CoV‑2 anti­gen in remo­te app­li­ca­ti­ons and without the need for com­plex labo­ra­to­ry instru­ments at effi­ci­ent cost and conveience.

Per­for­mance Characteristics 

BIOCREDIT COVID-19 Ag has been eva­lua­ted with panel spe­ci­men by PCR. The results are sum­ma­ri­zed in the fol­lowing table:

Sen­si­ti­vi­ty and Specificity 

Spe­ci­men Collection:

Assay Pro­ce­du­re:

Inter­pre­ta­ti­on of Results:

Cross reac­ti­vi­ty

BIOCREDIT COVID-19 Ag has been tes­ted with 20 poten­ti­al­ly cross reac­ting micro­or­ga­nisms and viru­ses. The results show­ed that BIOCREDIT COVID-19 Ag had no cross-reac­tion with micro­or­ga­nisms and viru­ses except very weak cross reac­ting with SARS-coronavirus.

Inter­fe­rence

BIOCREDIT COVID-19 Ag has been tes­ted with 14 poten­ti­al­ly inter­fe­ring endo­ge­nous or exo­ge­nous sub­s­tan­ces. The results show­ed that BIOCREDIT COVID-19 Ag had no inter­fe­rence with endo­ge­nous or exo­ge­nous sub­s­tan­ces except very weak inter­fe­rence with HAMA Type I.

KIT Com­pon­ents

• Each test device sea­led in a foil pouch with a desiccant
• Assay dilu­ent tube – Fil­ter cap
• Ste­ri­li­zed swab for nasopha­ryn­ge­al spe­ci­men collection
• Inst­ruc­tions for use

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

Important Information

This offer is exclu­si­ve to com­mer­cial cus­to­mers with qua­li­fied per­so­nel. This inclu­des: Doc­tors, out­pa­ti­ent and inpa­ti­ent faci­li­ties in health care, e.g. phy­sio­the­ra­py cli­nics, who­le­sa­lers and phar­maci­es, health aut­ho­ri­ties of the federal government, the federal sta­tes, the muni­ci­pa­li­ties and muni­ci­pal asso­cia­ti­ons, blood dona­ti­on ser­vices, phar­maceu­ti­cal com­pa­nies, advi­so­ry and test faci­li­ties for at risk people.

You con­firm that you are pla­cing the order for commercial/medical pur­po­ses and that you are han­ding over the pro­ducts to the appro­pria­te qua­li­fied personel.

Shipping

Plea­se note that due to high demand, deli­very may be take lon­ger than expected.

The regu­lar deli­very time is 3–5 work days.