COVID 19 Antigen rapidtest kit (Colloidal gold)

Summary Data

Cangzhou Yongkang Medical Devices Co.,Ltd

Tel : +86-19932220999

E-mail: goif@yongkangcn.com

目录

(Contents)

1、产品彩页（Product Brochure）

2、公司介绍（Company Profile）

4、符合性声明（Declaration of Conformity）

5、CE回执（CE Receipt）

6、说明书（Instructions for Use）

7、产品照片（Product Photos）

8、包装信息（Packing Information）

3、企业资质（Enterprise Qualification）

Company Profile

Cangzhou Yongkang Medical Devices Co., Ltd. is located in Daguanting Industrial Zone inthe west of Cangzhou City. It was established in 1999 and covers an area of 20,000 squaremeters with a registered capital of 36.68 million RMB. We have 110 employees, 12 productionlines for COVID19 (2019-nCoV) antigen rapid test kit (colloidal gold) and COVID19 (2019-nCoV) neutralizing antibody rapid test kit (colloidal gold ), 8 automatic production lines forvacuum blood collection tubes.

We are a joint-stock enterprise integrating biomedical technology development, productionand sales. The main products are medical biological antigen antibody detection and other seriesof in vitro diagnostic reagent products.

We have a professional scientific research management team composed of high-qualityintellectuals, and our sales and service network covers the world.

In 2004, the company passed the ISO9001 and ISO13485 quality system certification andthe European Union CE certification.Yongkang people persistently strive for perfection inproduct quality, are determined to innovate, and advance with the times to create a newgeneration of Yongkang glory!

Seite 1 von 3Druckdatum / Print date:

Datenauszug aus dem Österreichischen Register für Medizinprodukte (inkl. In-vitro Diagnostika, IVD) gemäß § 67 (1) und (2) des Medizinproduktegesetzes (MPG) sowie gemäß Medizinproduktemeldeverordnung 2011

Excerpt from the Austrian Medical Devices Registry (incl. In-vitro diagnostics IVD) according to § 67 (1) and (2) Austrian Medical Devices Act (MPG) and according to the Enactment on theRegistration of Medical Devices 2011

1. Zuständige Behörde / Competent Authority1

Code der zuständigen Behörde / Competent Authority Code AT/CA01

Bezeichnung der zuständigen Behörde / Competent Authority Name

Bundesministerium für Soziales, Gesundheit, Pflegeund Konsumentenschutz

Abteilung VIII/C/1 - Arzneimittel und Medizinprodukte, Blut, Gewebe und Transplantationswesen

Adresse der zuständigen Behörde / Address of the Competent Authority

Radetzkystraße 2

A-1030 Wien / Vienna, Austria

Telefon / Telephone Number +43 1 71100 644487

E-Mail martin.renhardt@sozialministerium.at

Website http://www.sozialministerium.at

2. Meldung zur Registrierung von IVD gemäß § 67 MPG (Erstmaliges Inverkehrbringen) /Registration of IVD according to § 67 MPG

Datum der Registrierung bei der zuständigen Behörde / Date of registration

Datum der letzten Änderung / Date of last change

Registrierungsnummer bei Erstregistrierung / Registration number at the date of the first registration

Aktuelle Registrierungsnummer (nach Änderung(en)) / Current registration number (after modification(s))

3. Zur Registrierung gemeldet von: / Reported by:

Verantwortliche Person/Organisation (Melder) für das Inverkehrbringen /

Status of person/organization (declarant) responsible for placing on the market

Hersteller von IVD / Manufacturer of IVD

Bevollmächtigter des Herstellers von IVD/ Authorised representative

Importeur / Importer

Vertreiber/Händler / Distributor

Registriernummer des Melders / Code of the declarant

Name des Melders / Name of the declarant

Straße und Hausnummer oder Postfach / Street, No.

Postleitzahl / ZIP code

Ort / City

Staat / Country

1 Gemäß den Bestimmungen des Medizinproduktegesetzes (MPG, BGBl. I Nr. 657/1996 i.d.g.F) und den Richtlinien der Europäischen Union über Medizinprodukte besteht eine gesetzliche Verpflichtung Österreichs zur Führung eines Registers für Medizinprodukte und In-vitro Diagnostika (IVD). Gemäß § 1 (2) der Medizinproduktemeldeverordnung wurde für die Umsetzung dieses Gesetzesauftrags die Gesundheit Österreich GmbH (GÖG) vom Bundesministerium für Soziales, Gesundheit, Pflegeund Konsumentenschutz mit der Einrichtung und laufenden Betreuung dieses Registers beauftragt. / According to the Austrian Medical Devices Act (MPG) and the corresponding EU Directives in Austria a legal obligation exists to implement a registry on medical devices and in-vitro diagnostics. According to the Enactment on the Registration of Medical Devices 2011 the Austrian Ministry of Social Affairs, Health, Care and Consumer Protection commissioned the Austrian Health Institute(GÖG) to set up and maintain the registry.

15.04.2021

Potsdam

OSMUNDA Medical Technology Service GmbH

AT/CA01/R005667-00

■

15.04.2021

Deutschland

Von Oppen-Weg 15

AT/CA01/I0018803-00

14476

AT/CA01/I0018803-01

Seite 2 von 3Druckdatum / Print date:

3. Zur Registrierung gemeldet von: / Reported by:

Kontaktperson: Name / Contact person: name

Telefon / Telephone Number

Telefax / Fax Number

E-Mail

Website

Sicherheitsbeauftragte/r für IVD gemäß § 78 MPG /

Safety officer for IVD acc. to § 78 MPG

Kontaktperson: Name / Contact person: name

Telefon / Telephone Number

Telefax / Fax Number

E-Mail

Im Falle einer Meldung als Bevollmächtigter,

Importeur oder Vertreiber/Händler (falls

zutreffend): Angabe des ausländischen

Herstellers außerhalb des Europäischen

Wirtschaftsraumes / In case of registering as

authorised representative, importer

or distributor (if applicable), indication

of manufacturer outside the European

Economic Area (EEA)

Name des ausländischen Herstellers / Name of the manufacturer outside the EEA

Straße und Hausnummer oder Postfach / Street, No.

Postleitzahl / ZIP code

Ort / City

Staat / Country

Kontaktperson: Name / Contact person: name

Telefon / Telephone Number

Telefax / Fax Number

E-Mail

Website

4. In-vitro Diagnostikum (IVD) / In-vitro diagnostic (IVD)

IVD-Klassifikation / IVD Classification IVD gemäß Anhang II, Liste A der EU-Richtlinie 98/79/EG / IVD acc. to MDD 98/79/EC List A, Annex II

IVD gemäß Anhang II, Liste B der EU-Richtlinie 98/79/EG / IVD acc. to MDD 98/79/EC List B, Annex II

IVD zur Eigenanwendung (falls nicht in Anhang II der EU-Richtlinie 98/79/EG / IVD for self-testing (if not listed in Annex II of MDD 98/79/EC)

Andere IVD / Other IVD

Neues Produkt im Sinne der EU-Richtlinie 98/79/EG / „New“ IVD according to MDD 98/79/EG

Ja / Yes

Code des IVD nach einer international anerkannten Nomenklatur für IVD (z.B. EDMS, GMDN) / Code from an internationally recognised nomenclature for in-vitro diagnostics

Falls vorhanden, Bezeichnung des IVD nach einer international anerkannten Nomenklatur für IVD / If available, code description from an internationally recognised nomenclature for IVD

5. Zusatzinformation für IVD gemäß Anhang II der Richtlinie 98/79/EG oder IVD zur Eigenanwendung /Additional information for IVD acc. to MDD 98/79/EC, Annex II or IVD for self-testing

Produktname oder –fabrikat / Product name

Konformitätsbewertung durch benannte Stelle / Conformity checked by Notified Body

http://en.osmundacn.com/

COVID19 (2019-nCoV) antigen rapid test kit (colloidal gold))

■

Yi Ling Tan

min.yang@osmundacn.com

15.04.2021

Cangzhou Yongkang Medical Devices Co.,Ltd

Hebei

Min Yang

+4930 5059 0627

+4930 5059 0627

ykghc@163.com

Yongkang Road, Daguanting Industrial Zone, Cang County, Cangzhou City

061734

15.04.80.90.00

Other Viral Antigen/Antibody Detection

+86-317-4928888

■

China

Hong Cai Gao

5. Zusatzinformation für IVD gemäß Anhang II der Richtlinie 98/79/EG oder IVD zur Eigenanwendung /Additional information for IVD acc. to MDD 98/79/EC, Annex II or IVD for self-testing

Identifikationsnummer der benannten Stelle / Notified Body Identification Number

Nur für IVD gemäß Anhang II, Liste A der Richtlinie 98/79/EG / For IVD acc. to MDD 98/79/EC, Annex II, List A only

Konformität mit den gemeinsamen technischen Spezifikationen / In conformity with the common specifications

Generischer Name / Generic name

Dieser Ausdruck ist keine amtliche Bestätigung und auch kein Zertifikat oder eine Konformitätserklärung. Die alleinige Verantwortung für die auf diesem Auszug enthaltenen Daten trägt die/der Registrierungspflichtige (Melder).

This form is no statutory confirmation and is not a certificate or a declaration of conformity.The registering person/organization (declarant) has the full responsibility for the information given in this form.

Kontakt für datenschutzrechtliche Rückfragen / Contact for data protection queries: datenschutzbeauftragte@goeg.at

Seite 3 von 3Druckdatum / Print date: 15.04.2021

Export whitelist:

COVID19 (2019-nCoV) antigen rapid test kit (colloidal gold )user's manual

【product name】

COVID19 (2019-nCoV) antigen rapid test kit (colloidal gold )

【Packing specification】

1 serving/box, 5 servings/box, 10 servings/box, 20 servings/box.

【expected usage】

Used for in vitro qualitative determination of the nucleocapsid protein (N protein) of the novel coronavirus in human nasal swabs and

nasopharyngeal swabs.

【Principle of Inspection】

COVID19 (2019-nCoV) antigen rapid test kit (colloidal gold ) is based on the principle of double antibody sandwich. When the sample

contains N protein, the sample combines with the gold-labeled anti-N protein antibody immobilized on the binding pad to form a reaction

complex. Under the action of chromatography, the reaction complex moves forward along the nitrocellulose membrane (NC membrane),

and when chromatographed to the position of the detection line (T line) on the NC membrane, it binds to the anti-N protein antibody

pre-coated on the membrane And form a double-antibody sandwich complex, while other irrelevant substances are filtered, and finally a

red mark that can be easily observed by the naked eye is formed on the T-line.

When the gold-labeled chicken IgY complex is chromatographed to the position of the quality control line (line C), it combines with the

goat anti-chicken IgY antibody pre-coated on the membrane to form a red blot that can be easily observed by the naked eye. Regardless of

whether the sample contains N protein, the quality control line should have a red mark. If there is no red mark on the quality control line,

the sample must be tested again.

【Main components】The new crown antigen kit consists of binding pad, nitrocellulose membrane, absorbent paper, PVC board and other

test strip supports, nitrocellulose membrane coated with anti-N protein monoclonal antibody (>0.5mg/mL) and goat anti-chicken IgY

polyclonal antibody (>0.5mg/mL), the binding pad is mainly composed of gold-labeled anti-N protein monoclonal (>0.01μ g) and

gold-labeled chicken IgY (>0.1μg), and a plastic card shell. According to different specifications of new crown antigen kits, collection

tubes (lysate), swabs, instructions, workstations, etc.

【Storage conditions and expiry date】

Store at 4℃～30℃, the validity period is 12 months. After the reagent card is opened, it should be used as soon as possible within 1

hour.

【Sample Collection】

nasal swab using method:

1. Insert the swab into one of the patient's nasal cavity. The flocking end should be inserted one inch from the edge of the nasal

cavity. Roll the swab five times along the inside of the nasal cavity to ensure that the mucus and cells are collected.

2. Repeat the process for the other nasal cavity with the same swab to ensure that enough samples are obtained from both nasal cavities.

3.Pull the swab out of the nasal cavity.

nasopharyngeal swab using method:

1. Put the patient's head back slightly.

2. Insert the flocking end along the nasal septum gently into the nasopharynx until resistance is met. Rotate the swab several times.

3. Put the swab in place for a few seconds, and then remove it from the nasopharynx.

Note: 1) Specimen collection and processing: Insufficient specimen collection or improper specimen processing can lead to erroneous

results.

2) Patients should be instructed to remove secretions from the anterior nasal passages before collecting nasal swabs and

nasopharyngeal swabs.

[Sample transportation and storage]

Samples that need to be processed within 24 hours can be stored at 4°C; samples that cannot be processed within 24 hours should

be stored at -70°C or lower (if there is no storage condition of -70°C, they should be stored Temporarily store in the refrigerator at -20°

C). Please do not use specimens that grow bacteria, and specimens that have been stored for too long or repeatedly frozen and thawed to

avoid non-specific reactions caused by specimen contamination or bacterial growth.

【Sample Preparation】

1. Open the extraction tube and place it on the workstation.

2. Insert the sampled swab into the extraction tube filled with buffer. Rotate the swab at least 10 times while pressing the flocking end

toward the bottom and sides of the extraction tube.

3. Squeeze the extraction tube with your fingers, and then roll the flocking head toward the inside of the extraction tube to take it out to

release as much liquid as possible. The extracted solution is used as a test sample.

4. Insert the dripper firmly into the sample collection tube. Test procedure Before testing, make the tester and sample to equilibrate to room

temperature (15-30°C or 59-86°F).

Note: This reagent is equipped with any of the following two extraction tubes (see figure), only the appearance is different, and there is no

difference in the method of use and function.

【Testing method】

1. Before testing, please read the instruction manual carefully. The test box, sample extraction solution and sample need to be

equilibrated to room temperature.

2. Preparation of specimen solution:

a. Open the lid of the collection tube and place it in the workstation.

b. Pick up the collection tube and insert the swab into it. Dip the swab up or down for at least 15 seconds, taking care not to spill the

contents out of the test tube.

c. Take out the swab while pinching, rotate the swab to stick to the tube wall, and withdraw the swab.

d. Cover the collection tube with the tip of a dropper.

3. Remove the test card from the sealed bag

4. Specimen addition: Put the collection tube straight down, and then pinch the wall of the test tube to make the specimen drip out of the

test tube. Add 3 drops of sample solution to the sample hole (S) of the sample box, and then wait for the result to appear. Avoid adding

bubbles when dripping.

5.Timed observation: The result is judged 15 minutes after adding the specimen, and the result is not observed after 20 minutes.

[Explanation of test results]

Positive Two lines appear, regardless of the strength of the test line, one colored line appears in the control

area (C), and the other colored line appears in the test area (T).

Negative A colored line appears on the control area (C), but no line appears on the test area (T)

Invalid The control line cannot be displayed. Insufficient sample size or incorrect processing technology is

the most likely cause of control line failure. Review the steps and repeat the test with a new test

box. If the problem persists, please stop using the batch immediately and contact your local

distributor.

【Limitations of the method of operation】

1. The content of this kit is used to qualitatively detect SARS-CoV-2 antigen in nasal swabs.

2. If the antigen level in the sample is lower than the detection limit of the test or the sample is improperly collected or transported, a

negative result may be produced.

3. Failure to follow the test procedures may adversely affect test performance and/or invalidate test results.

4. The test results must be evaluated in conjunction with other clinical data available to the doctor.

5. A positive test result does not rule out simultaneous infection with other pathogens.

6. A negative test result is not intended to exclude other non-SARS virus or bacterial infections.

7. A negative result should be regarded as a presumptive result and confirmed by molecular assays when necessary for clinical

management, including infection control.

8. Frozen samples are used to assess clinical performance, while fresh samples may perform differently.

9. If you need to distinguish between specific SARS viruses and strains, other tests are needed.

10. This product has been evaluated and can only be used with human specimen materials.

【Product performance characteristics】

1．Negative coincidence rate: Use negative reference materials to test, the results should all be negative.

2．Positive coincidence rate: Use a positive reference product for testing, and the results should all be positive.

3．Lowest detection limit: Use the lowest detection limit reference for testing, and the result should be positive.

4．Repeatability: Use the repeatability reference product to test 10 persons in parallel, the response results should be consistent, and

the color rendering should be uniform and there is no difference.

【Warnings and precautions】

1. For in vitro diagnosis.

2. Appropriate precautions should be taken when collecting, processing, storing and disposing of patient samples and the contents of used

kits.

3. When handling patient specimens, it is recommended to use nitrile, latex (or similar) gloves.

4. Do not reuse used test boxes, specimen processing tubes or swabs, etc.

5. The user must not open the aluminum foil bag of the test box and expose it to the surrounding environment before using it immediately.

6. If the sample extract comes into contact with the skin or eyes, please rinse with plenty of water.

7. In order to obtain accurate results, the instruction manual must be followed.

8. Inadequate or improper sample collection, storage and transportation may produce erroneous test results.

9. Specimen collection and processing procedures require specific training and guidance.

10. When collecting specimens, please use the swab provided in the kit. Using other swabs may result in false negative results.

11.For accurate results, do not use open and bare test boxes in laminar flow fume hoods or poorly ventilated places, and do not use blood

samples or excessively viscous specimens.

12. The test should be carried out in a well-ventilated area.

13. When handling the items in the kit, please wear appropriate protective clothing, gloves and eye/face protection.

14. Wash hands thoroughly after handling.

15. Pathogenic microorganisms may be present in clinical specimens, including hepatitis virus and human immunodeficiency virus.

Standard precautions and institutional guidelines should always be followed when handling, storing, and disposing of all specimens and

articles contaminated by blood or other body fluids.

16. The used test box should be discarded in accordance with federal, state and local regulations.

17. Note: If the sample is contaminated or abnormal, or the sample processing method and test method are not performed in accordance

with the instruction manual, the result will be wrong, which has nothing to do with product quality.

【Clinical performance】

A total of 200 confirmed cases of new coronary pneumonia and excluded cases were tested. The clinical sensitivity of this kit is 96.97%

(95% confidence interval is 93.42%-98.93%), and the clinical specificity is 100% (95% confidence interval is 98.97) %-100%).

Nasal swab test results:gold standard

total＋ －

Reagent testresults

＋ 45 0 47

－ 2 53 53

total 47 53 100

Nasopharyngeal swab test results:gold standard(serum)

total＋ －

Reagent test results＋ 51 0 52

－ 1 48 48

total 52 48 100

【Cross reaction】

Through the cross-reaction verification of virus and bacteria infection, it is confirmed that the presence of the following viruses and

bacteria will not interfere with the test results.

microorganism concentration Whether there is cross-reaction or not

InfluenzaA virus (H1N1, H3N2) 1.0 x 105 TCID50/mL no

Avian influenza (H5N1, H7N9) 1.7 x 105 TCID50/mL no

Influenza B virus (Yamagata, Victoria) 2.5 x 105 TCID50/mL no

Parainfluenza virus 1.0 x 105 TCID50/mL no

Respiratory syncytial virus 3.8 x 105 TCID50/mL no

Rhinovirus 1.4 x 105 TCID50/mL no

Mumps virus 1.1 x 105 TCID50/mL no

Measles virus 1.0 x 106 TCID50/mL no

Endemic human coronavirus (OC43, NL63 and 229E) 1.0 x 105 TCID50/mL no

MERS coronavirus 1.2 x 105 TCID50/mL no

Mycoplasma pneumoniae 1.0 x 106 CFU/mL no

Chlamydia pneumoniae 1.0 x 106 CFU/mL no

Legionella 1.1 x 106 CFU/mL no

Staphylococcus aureus 5.0 x 106 CFU/mL no

Basic informationRegistrant/Manufacturer : Cangzhou Yongkang Medical Devices Co.,LtdRegistered address : 1Yongkang Road, Daguanting Industrial Zone, Cang County, Cangzhou City, Hebei Province,ChinaE-mail : goif@yongkangcn.com Tel : +8619932220999 +8616630826666European Authorized Representative

OSMUNDA Medical Technology Service GmbHAddress:VonOppen-Weg 15, 14476 Potsdam, GermanyE-Mail:eu@osmundacn.com Tel:+49-30-5059-0627 Fax: +49-30-2215-0446Instructions Manual Revision Date and Version RevisionDate:2021.01.05 Version No.:2.4

Attention, seeinstruction foruse

Expiry Catalogue

For in vitrodiagnostic useonly

Lot number European AuthorizedRepresentative

Store at 4-30℃ Manufacturer Keep dry

Test per kit Do not reuse Warning and PrecautionsDon't use the product when the packageis damaged Keep away from sunlight

COVID 19 Antigen rapid test kit (Colloidal

gold ) Product photos

COVID 19 Antigen rapid test kit (Colloidal

gold) Product photos

抗原胶体金检测试剂包装信息COVID 19 Antigen rapid test kit (Colloidal

gold ) Packing Information

产品名称

Product name

规格/盒Specifications

单位

Unit

单位包装毛重

Gross weight per

unit package

COVID 19 Antigen rapid test .

kit (Colloidal gold )

20 tests/box

尺寸（Size）：180x120x80mm

盒/box 0.28 kg/盒0.28 kg / box