Gentaur SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Contents

Instruction for SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

1. Product Name
Generic name: SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Trade name: SARS-CoV-2 Antigen
2. Package
Specification 1: 1T/kit REF: 52104081
Specification 2: 5T/kit REF: 52112079
Specification 3: 10T/kit REF: 52025096
Specification 4: 25T/kit REF: 52026075
Specification 5: 50T/kit REF: 52027077
3. Intended Use & Indication
Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) is an immunochromatographic
assay for rapid, qualitative detection of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) antigen from the nasopharyngeal swab or opharyngeal
swab specimen. The test is to be used as an aid in the diagnosis of coronavirus
infection disease (COVID-19), which is caused by SARS-CoV-2.
The test provides preliminary test results. Negative results cannot exclude
SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or
other management decision.
For in vitro diagnostic use only. For professional use only.
4. Test Principle
This product uses highly specific antibody-antigen reaction and colloidal gold
immunochromatographic technology. The reagent contains anti- SARS-CoV-2
monoclonal antibodies pre-fixed on the test area (T) on the membrane and anti
SARS-CoV-2 monoclonal antibody gold-labeled conjugate labeled on the gold label
pad.
During the test, the processed sample to be tested is dropped into the reagent
loading place. When the sample contains SARS-CoV-2 antigen, the SARS-CoV-2
antigen in the sample is first combined with the anti- SARS-CoV-2 antibody labeled
with colloidal gold, and then the conjugate is chromatographed upward under the
capillary effect, and it will be pre-immobilized on another membrane on the
membrane. When the anti- SARS-CoV-2 monoclonal antibody binds, a purple-red
band will appear in the test area (T). If there is no SARS-CoV-2 antigen in the sample,
there will be no purple-red band in the test area (T). Regardless of whether the novel
coronavirus antigen is present in the sample, a purple-red band will appear in the
quality control area (C). The purple-red band in the quality control area (C) is the
standard for judging whether there are enough samples and whether the
chromatography process is normal, and it also serves as an internal control standard
for reagents.
5. Precaution
(1) This kit is for in vitro diagnostic use only.
(2) All specimens should be treated as capable of transmitting diseases. Use
appropriate precautions in the collection, handling, storage and disposal of patient
samples and used kit contents.
(3) Wear appropriate personal protective equipment (e.g. protective gloves, medical
mask, goggles and lab coat) when handing the contents of this kit.
(4) If the virus sampling solution is used for specimen processing, it can be directly
detected without using extraction buffer.
(5) Proper specimen collection, storage and transport are critical to the performance
of this test.
(6) Discard after first use. The sample extraction tube, the dropper and the test
device cannot be reused.
(7) Avoid high temperature during the experiment. Test cards and detection buffer
stored at low temperature must be brought to room temperature before opening to
avoid moisture absorption.
(8) Do not touch the reaction area of test strip.
(9)Do not use test kit beyond the expiration date.
(10)Do not use the kit if the pouch is punctured or not well sealed.
(11)Testing should be applied by professionally trained staff working in certified
laboratories or clinics at which the sample(s) is taken by qualified medical personnel.
(12) The test result should be interpreted by the physician along with clinical findings
and other laboratory test results.
(13) Disposal of the diagnostic kits: All specimens and the used-kit have the
infectious risk. The process of disposing the diagnostic kits must follow the local
infectious disposal law or laboratory regulation.
6. Main Components& Additional required equipment
The test kit consists of test card, sample diluent, extraction tube and the instruction.
(1) The test card consists of the card housing and test strip. Test strip contains a
sample pad, glass fiber (Colloidal gold labeled anti-SARS-CoV-2 monoclonal
antibody), nitrocellulose (NC) membrane (test area (T) is coated with
anti-SARS-CoV-2 monoclonal antibody, quality control area (C) is coated with goat
anti-mouse antibody, absorbent paper and PVC plate.
(2) Sample diluent: the main component is phosphate buffer (PBS).
7. Accessories Required But Not Provided
(1) Nasopharyngeal swab or oropharyngeal swab
(2) Viral Transport Media (VTM)
(3) Tongue depressor
(4) Extraction tube holder
(5) Timer
(6) Personal protective equipment, such a protective gloves, medical mask, goggles
and lab coat.
(7) Appropriate biohazard waste container and disinfectants.
8. Storage & Transport conditions
(1) The test kit can be stored at 2-30℃, aluminum foil bag in a sealed state is valid for
18 months , once opened, it is valid for 1 hour when the humidity is less than 65%.
Make sure to use the product immediately after opening the packing bags when
humidity is higher than 65%. The opening period of sample solution is 1 month. And
the production date is shown in the outer packing box.
(2) Transport at 2-30℃.
9. Sample Requirements
(1) Both human oropharyngeal swab and nasopharyngeal swab can be used for
testing.
(2) The sample should be used as soon as possible after collection. If it cannot be
used immediately, it must be stored at 2-8°C within 3 days. For long-term storage, it
must be stored frozen below -70°C.
(3) The samples must be returned to room temperature (18-28°C) before testing. The
frozen samples must be completely thawed, rewarmed, and mixed before use.
10. Specimen Collection And Preparation
The test can be performed with oropharyngeal swab and nasopharyngeal swab
specimen.
(1) According to standard nasopharyngeal swab or oropharyngeal swab specimen
collection procedure.
(2)nasopharyngeal swab specimen collection: Tilt patient’s head back 70 degrees.
Insert swab into nostril (Swab should reach depth equal to distance from nostrils to
outer opening of the ear). Leave swab in place for several seconds to absorb
secretions. Slowly remove swab while rotating it.
(3) Oropharyngeal swab specimen collection: Insert swab into the posterior pharyn

Genbody exporteert Covid-19, multi-diagnosekit voor influenza

GenBody Influenza / COVID-19 Ag Multi

, een snelle diagnostische testkit voor antigeen voor Covid-19 en influenza, op de wereldmarkt zou lanceren.

Genbody heeft vrijdag de exportgoedkeuring voor GenBody Influenza / COVID-Ag Multi gewonnen van het Ministerie van Voedsel- en Drugsveiligheid.

“De kit kan gelijktijdig in slechts 15 minuten controleren op Covid-19 en influenza-infectie, en is goedkoop en gemakkelijk te gebruiken in het veld zonder aanvullende medische apparatuur”,

“Onze multidiagnoseset kan snel onderscheid maken tussen de twee ziekten, die gelijkaardige ademhalingssymptomen zijn met een hoge overdrachtssnelheid.”

Het bedrijf zei dat zijn testkit de goedkeuring heeft gekregen van het Ministerie van Voedsel- en Geneesmiddelenveiligheid om de twee ziekten tegelijkertijd te testen Voor de eerste keer.

Genbody CTO Jung Jum-kyu zei: “Aangezien Covid-19 naar verwachting in de nabije toekomst zal voortduren, is een snelle reactie nodig als een bijkomende crisis, waaronder de grieppandemie, nadert.”