Instructions - Covid-19 Rapid Antibody IgG IgM Test Kits

"serology test" "serologic testing" or "serological diagnostics"

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Novel Coronavirus (SARS-Cov-2)

10-15 Minute Antigen Rapid Swab Test Cassette

CE Certificate

Box contents

  • 5 Novel Coronavirus (SARS-Cov-2) Test Cassettes

  • 5x Sterilised Swabs

  • 5x Extraction Tubes

  • 5x Nozzle’s with filter

  • 1 Sample Extraction Buffer Fluid

  • Package Insert

  • Tube Stand

  • User instructions in English

Items required

  • Timer

Clinical evaluation

Clinical evaluation was performed to compare the results obtained by Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) and PCR. The results were summarised as follows:

 

Clinical Results

Clinical Specificity 99.9%

Clinical Sensitivity 90.32%

Accuracy 97.71%

 

Summary

COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhoea are found in a few cases.

What is an Antigen Swab Test?

An antigen swab test is very similar to a PCR test for the effective diagnosis of COVID-19.  The test checks for viral proteins from a sample taken from the nose with a swab and can be performed much faster than a PCR test as the samples taken from the nose swab and do not need to be taken to a laboratory for analysis and can be analysed onsite.  The Antigen swab test is a diagnostic test can tell you whether you have a current infection of COVID.  The antigen test is much quicker than a PCR test, taking around 10 minutes to to analyse a nose swab sample and are easy and simple to operate.

 

Intended use

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in nasopharyngeal swab and Oropharyngeal swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen.  The test is used for the rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate.

 

Warning & Precaution

Samples should be considered as potentially infectious. The operator should wear protective clothing, masks, and gloves and take other appropriate safety precautions to avoid or reduce the risk of infection.

 

Storage Conditions

Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial, minimum 18 months. The test cassette which is sealed inside the aluminium foil bag should be used immediately upon opening.

 

Specimen Collection & Preparation

1. Specimen Collection

 

This swab test is applicable to the diagnosis of the Novel coronavirus from the samples of Nasopharyngeal swab.  Use freshly collected samples for optimal test performance.  Inadequate sample collection or improper sample handling may yield a false-negative result.  For nasopharyngeal (Nose) swab completely insert the sterilized swab supplied in this kit into thenasal basin, and swab several times to collect the epidermal cells of the mucus.  For oropharyngeal (Throat) swab completely insert the sterilized swab supplied in this kit into the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.  It is recommended to collect sample from Nasopharyngeal (Nose) for more accurate results.

 

2. Specimen preparation:


1) Add 10 drops (about 0.3 ml) of the sample extraction buffer into the extraction tube supplied in this kit, and put it on the tube stand.


2) Nasopharyngeal and oropharyngeal Swabbing
Insert the swab into the extraction tube which contains 10 drops (about 0.3 ml) of the sampleextraction buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that liquid is expressed and reabsorbed from the swab, remove the swab. The extracted solution will be used as test sample.

 

Test Procedure

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.

 

Wear protected equipment before beginning test


1.Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.


2. Unscrew the whole cap of the specimen collection tube.


3. Add 10 drops (about 0.3 ml) of the sample extraction buffer into the extraction tube.


4. Place the sterilised swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.


5. Remove the sterilised swab while squeezing the sterilised swab head against the inside of the buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilised swab in accordance with your bio-hazard waste disposal protocol.


6. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer.


7. Add 3 drops of the solution (approx.80ul) to the sample well and then start the timer. Read the result at 10-20 minutes. Don’t interpret the result after 20 minutes.

 

8.  Set timer for 10 minutes and wait for the coloured lines on the test cassette to appear

 

9.  Take photo of test results with a smartphone for later verification

 

10. Read the test results from the test cassette in 10-20 minutes or later from the smart phone photo

11. Do not interpret the results after 20 minutes

 

12. For health & safety dispose of the lancet, gloves, foil packaging and test cassette in bin

How to Interpret Results

 NEGATIVE 

Only one red line appears in the control region(C), and no line in the test region (T).  The negative result indicates that there are no Novel coronavirus particles in the sample or the number of viral particles is below the detectable range

 POSITIVE 

Two red lines appear. One red line appears in the control region(C), and one red line in the test region (T).  The shade of colour may vary but it should be considered positive whenever there is even a faint line.

 INVALID 

No red line appears in the control region(C). The test is invalid even if there is a line on test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Principle

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coronavirus.


The test device is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The whole strip is fixed inside a plastic device. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilised on the membrane.


When the sample is added into the sample window, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If Novel coronavirus is present in the sample, a complex formed between the anti- Novel coronavirus conjugate and the virus will be caught by the specific anti- Novel coronavirus monoclonal coated on the T region.


Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.

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Professional Use

Important

This test kit is a complement to PCR detection in COVID-19 diagnosis

Reagents
The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.

EC Representative

Luxus Lebenswelt GmbH
Kochstr. 1,47877, Willich, Germany

© 2020 All rights reserved  C-19 Tests & Diagnostics 

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