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抗原快速測試劑使用指南

Goldsite Covid-19 rapid antigen test kit instruction

The self test of Covid-19 antigen is one of the key guards to protect you and your family from the harm of the disease.Government appeals citizens to prepare rapid test kit and test themselves daily.There are many types of rapid tests kits in the market ,the price range varies so does the quality. Gogo herb will introduce CE qualified Goldsite Covid-19 rapid antigen test kit to you ,this will help get you well soon as possible.

What is the Goldsite Covid-19 antigen test kit?

Goldsite is a disposable test kit for in vitro rapid Immunochromatographic detection.It qualitatively detects the SARS-CoV-2 nucleocapsid N antigen in human nasal cavity swap sample to screen the existence of SARS-CoV-2 protein antigen in human body.

Principle of Goldsite rapid antigen test kit

The Goldsite reagent adopts lateral flow immunoassay technology.Its test card is able to rapidly detect SARS-CoV-2 protein.To proceed the test,you place the nasal cavity swab sample taken by yourself into the sample tube.The solution inside the sample tube reacts with the swap sample and stimulates the exposure of the virus antigen to the prepared antibody in solution .Extract the mixed solution from the sample and place the mixed solution in the test sink of the test box.If the SARS-CoV-2 antigen exists in the swap sample ,a pink or red stripe will appear by the T sign on the result indication area .And the program comparative section C will show a red stripe as well.When no strip shows by the T sign ,it means the nonexistence of SARS-CoV-2 antigen or the level of SARS-CoV-2 existence is lower than the bottom limit value of the test standard.

Certification acquired by Goldsite Covid-19 rapid antigen test kit

  • EU CE 1434 certification
  • Qualified for Germany BfArM Professional Use Test
  • Qualified for French ANSM Self test (for professional use & self-testing)
  • Registration of Italy Self test purpose
  • Qualified for DHSC 3 Phase Evaluation(The great Britan)
  • Qualified for AEMPS Registration(Spain)

Origin of Goldsite Covid-19 rapid antigen test kit and research & development institute.

Goldsite Diagnostics Inc, founded in 1999 April,is situated in Shenzhen, China.For over 20 years, they have been developing and providing high quality products, from analyzer of specific protein,chemiluminiscence,automatic biochemistry,HPLC glycosylated hemoglobin ,time-resolved fluorescence immunoassay to matching reagents and other categories.Their service applies to over 7000 medical and health institutions,and over 600 A-grade hospitals. Their products spread to over 50 countries and areas ,among which the CE certified items, patent authorized and software copyright adds up to almost 100 pieces.

Content of Goldsite Covid-19 rapid antigen test kit

  • 1 painless nasal cavity stick
  • 1 antigen extraction tube
  • 1 guidance
  • 1 test device
  • 1 package bag
  • 1 package box

5 main advantages of Goldsite Covid-19 rapid antigen test kit

  • 12 minutes to get the test result
  • Nasal cavity swab sampling
  • Accuracy up to 97%
  • Accquired certification in a number of countries ,widely acknowledged quality
  • Sensitive detection of [Omicron] and [Delta mutation] virus.

Applicable population for Goldsite Covid-19 rapid antigen test kit

Novel corona virus(2019-nCoV)antigen test kit(colloidal gold method) is suitable to perform a self test ,no requirement for professional medical knowledge or professional condition.It’s a fast way to screen the SARS-CoV-2 infection preliminarily.Children under 15 and above 2 should take the test with guidance of an adult.The timely detection of SARS-CoV-2 will be largely beneficial for professional medical treatment to the patient and the disease control in community.

The use of Goldsite Covid-19 rapid antigen test kit should include 4 procedures.

1.Sample collection,place the nasal stick into both nasal cavity and rotate clockwise and anticlockwise gently.
2.Prepare the sample,put the nasal stick into the reagent tube and stir thoroughly.Remove the stick and close the cap of the tube.
3.Start the test by turning the tube up and down vertically for several time .Drip 2 drop of reagent into the test well.kit a timer for 12 minutes
4.Wait and read the test result when time’s up.Please notice ,the test result will turn invalid after 15 minutes ,please follow the procedures and keep track of time.

Goldsite Covid-19 rapid antigen test result interpretation

  • Positive test result of virus antigen:A red stripe appears beside the [C] sign and another red stripe appears beside the [T] sign
  • Negative test result of virus antigen:only one red stripe appears beside the C sign
  • Invalid test result:Only one red stripe appears beside the [T] sign,or no stripes appears at all.In this case ,the test needed to be done once again with a new pack of test kit.

Notice of using Goldsite Covid-19 rapid antigen test kit

  • For In vitro examination
  • Please read the instruction carefully before use and follow the guidance
  • If the package is broken ,the sign is vague, or the test kit expires ,please stop using it.
  • Please don’t open the tin foil bag with test device if you would not use it instantly.
  • Do not eat the desiccant
  • The test kit including its contents (test box,extraction tube, and sample stick)are for one-time use only
  • Do not mix or swap the reagent in different product batches
  • Avoid touching the tip when using the sample stick
  • The inappropriate and inadequate sampling will affect the accuracy of test ,it may generate false negative test result
  • Discard the test box and the sample properly at household waste
  • It’s suggested to take sample and perform the test with gloves on

Goldsite Covid-19 antigen test kit result clinical analysis.

In the acute phase of the infection,antigen usually can be detected in the nasal cavity sample.The positive result only manifests the existence of of virus antigen,but it should be considered with the medical history of a patient and other diagnosis information before any decision of the infection status is made.The positive result can also be caused by bacteria infection and combined infection of other virus.In other words,the antigen detected positive in sample does not directly link to the certain infection of covid-19

A negative result should be taken as assumption. If necessary ,please take molecule examination for more exact diagnosis.The negative result does not necessarily exclude the infection of Covid-19 virus,it should not be the only medical evidence regarding the treatment of a patient or disease control management in the community.The negative test result should be considered with the tester’s recent exposure to the disease, medical history, clinical signs and symptoms and other overall evaluation consistent of the infection of covid-19 before any medical or policy decision is made. When a tester has continuously cough ,fever and accelerated breathing,please seek for professional advice and attention even if the test result indicates negative.

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[Covid -19 rapid self test kit] YHLO/GOLDSITE/Green Spring/Hotgen/Abbott Panbio - Gogoherbs

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