CE Certification  Medical Device Supplier – Rapid SARS-CoV-2 Antigen Test Card – CILIANG

Rapid 2019-nCoV IqG/IqM Combo Tost Cnrd ts nn •mmunoenromatOQraphy based one step in vitro tost It « d<>siQfi©d for tho fuptd Qualitative delmmlnMion of IflG nr>d IflM antitxxJios to 2019 novel coronavirus (2019 nCoV. SARS CoV-2) in human somm mmA. oc whole btood Rapid 2019-nCoV IgG/IgM Combo Tost Cnrd is a supplomont detection for COVID-19 BKpoctod infectod patents bosidot nudoic nod tost which could groally the accuracy of tho cieloction (or COVID19

SUMMARY

Tho ”W coronnvirusos tx>lonq to tbo P genus COVID-19 H nn acute respiratory infoctous disease Poop«o om Oonocnlly suscoptiWo Currently, tho patients infected by the novel coronavirus nro tho main source ot mfoebon. n^ywplomatic mfoefod poog cah Also be an mfoebous source on the current ©p<demolog»cal invostigntion. the incubdbon ponod is 1 to 14 days. mosUy 3 to 7 du” Tbo e•仍 maoifostabons include fowr fabguo and dry cough Nawl congestion runny noso. sore throat, myalgia and dianhea nro found in a few cases

PRINCIPLE

Rnpxl 2019-nCoV Combo Test Card utilizes the pnnoplo of immuno^nromotoflrap^y. Mqum ant>-human igM and mouse miti human igG Aniitxxlies nro immoeniizod on tho ntfroceHutose meentxane respectively, as two individual tost tines (igM line aM IgG bno) in the test window of the test device The IgM line tn the test wndew * ctoier to the umple well fottowed by IgG itnc As the lest sample ftown through the membrane within IM test device the colored 2019-nCoV recomt>nant 90M conjugate forms comptexes with specific

nntibodios (IgM an<j/or IgG) to 2019 novel coronavirus if present in the sample This complex moves further on tho membrane to the test regs *er@ rt is captured by the mouse anb-humsn IgM and/<x mouse ant^umar I9G antibodies coated on the leaEg to formation of a colored band, stuch indicates positive test results.

Absence of tg cokxed band in the test window indicates a ne^at/vo test result A bwn-<n control bne wui atways appear m the tost window wtien the test »s porform^d propenrogdMiess ot the presecKe 8 absence of anb-2019 noveJ coronavirus antibodies In rhe specimen

MATERIALS PROVIDED

1 Raprt 2019-nCoV IgG-lgM Combo Test Card

2 Sample buffer

2 pL capillary pipet 4 Instructions for Use

MATERIALS REQUIRED BUT NOT SUPPLIED

Clock or timer, safety lancets, alcohol prep<pad spocamcn cxMlocton container, centrifuge, txohazard waste container disposable gloves, disinfectant

STORAGE

Store the tost device at 4 to 30°C in the onflinnl soalod pouch Do Not Froozo.
The expirabon date if>dicaie<J on the pouch was e$wbii$hod under thew storage coodibons
The lest device should remain in fts original sealed pouch until ready for use. After opening, tho test device should be used immediately. Do not reuso the device.

PRECAUTIONS

1 For professional in vitro diagnostic uso only

2 The product •$ stncUy for medical professional u$e only tod 曲 mwoded for personal use

3 Do not use lhe product beyond the exprsbon date

4 Do not the product if the pouch，$ darnaged or tM $«ai is txoken

5 Handle all specimens as potentially infectious

6 Follow standard Lat> procedure aM tMOsafety fluxMhnet for and disposal of potemiaii/ infectious

material When the assay proceduro is completed, dispo&e specimens after autoclaving at 121P kx at least 20 min Of treating with 0 5% Sodium HypochJonte f<x 1-2 hour*

SPECIMEN COLLECTION ANO PREPARATION

1 The serum, plasma or whole blood specimen should be coliedod uruSer standard iatxxatory conditions.

2 Heat inacbvatKX) of specimens, wtuch may causo hemolyse and proton denaturation, should be avoided

3 The test works best on fresh whole blood / serum i plasma samples If testing cannot be performed immediately, serum I plasma may be stored at 2-8°C up to 3 days in case of (Way m testing For long-term storage, serum / plasma speamens can be frozen at ・20*C lor 3 months or ・70°C tef longer penod Avoid repeated freezjng/thavwng cycles.

4 Sodium az>de can be added as a preservative up to 0.1% without affecting the test results