Panodyne Antigen Test Kit

Antigen Rapid Test Kit

Product Code: PDRTKTA-U

SARS-CoV-2 Overview

The novel corona viruses belong to the β genus. SARSCoV-2 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel corona virus 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.

Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

Benefits

  • Rapid testing for SARS-CoV-2 antigen within 15 minutes
  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • All necessary reagents provided and no equipment needed
  • High sensitivity and specificity

Contents

  • 1 Test cassettes
  • 1 Sterile swabs
  • 1 Sample extraction tube
  • 1 Dropper tip
  • 1 Package insert

Intended Use

The SARS-CoV-2 Antigen Rapid Test is intended for in vitro qualitative detection to SARS-CoV-2 antigen in human nasopharyngeal swab or oropharyngeal swab samples.

Specification

Information:

In detail

Time to result:

15 minutes

Storage:

2-30˚C

Shelf life:

24 months

Specimen type:

Nasopharyngeal swab or oropharyngeal swab

Performance Characteristics

SARS-CoV-2 Antigen Rapid Test Performance against with Comparator Method (nasopharyngeal swab/oropharyngeal swab)

SARS-CoV-2 Antigen Test
Positive
Negative
Total

Positive

206

3

209

Negative

3

306

309

Total

209

309

518

PPA: 90.91% (95%CI: 76.43%-96.86%)
NPA: 99.02% (95%CI: 94.66%-99.83%)
OPA: 97.04% (95%CI: 92.63%-98.84%)

EXPLANATION OF TERMS:
PPA: Positive Percent Agreement = True Positives / True Positives + False Negatives
NPA: Negative Percent Agreement = True Negatives / True Negatives + False Positives.
OPA: Overall Percent Agreement = True Positives + True Negatives / Total


Test Procedure and Interpretation

Specimen collection
Use the nasopharyngeal swab or oropharyngeal swab supplied in the kit.

1. Nasopharyngeal swab collection method:

  1. The operator holds the swab by the right hand and holds the head of the person firmly with the left hand. Insert the swab down towards the bottom of the nasal cavity and penetrate slowly and gently. Do not overexert to avoid traumatic haemorrhage.

  1. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it.

2. Collection method of oropharyngeal swab:

  1. The head of the person should be slightly tilted and their mouth wide open, exposing the pharyngeal tonsils on both sides.

  1. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a little force for at least three times, and then wipe up and down the posterior pharyngeal wall for at least three times. Avoid touching teeth and gums.

Sample preparation

Add 500μl (~20 drops) of sample extract to the 0.5 mark of the sampling tube, dip the swab after collecting the sample into the sample extract, make the sample extract fully permeate the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as the sample to be tested.

Test procedure and interpretation of results

Ordering Information

Description:

SARS-CoV-2 Antigen Rapid Test

Time to result:

Nasopharyngeal swab or oropharyngeal swab

Cat. No:

-

Format:

Cassette

Kit size:

1 Tests / kit

Panodyne Antigen 24 test kits

Test Kit A:
Requires extraction buffer to be added to the extraction tube.

Test kit B:
Contains pre-filled and measured buffer.


Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Antigen Test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.

Arrange COVID testing and minimise disruption to your business

Panodyne have partnered up with BNR Global Supply Group Ltd, who have developed a secure IT platform and dedicated business solution for keeping track of testing outcomes and keeping your workplace covid secure.

Key Features:

  • Tailored User Training: Simple user training provided as well as individual access to registration portal.
  • Live Alert System: As soon as a positive test is logged, management will be alerted immediately.
  • Result and Data Management: Stay on top of test outcomes and analyse data to provide a prompt response to outbreaks.
  • Dedicated Healthcare Helpline: Accessible for any healthcare related enquiries.
  • Telephone/Email Support: We're here to provide you with technical support

With a simple set up, users will be able to access a secure portal (accessible via computer or mobile phone) to register to this service and upload test results. Just simply activate the link and register your details, and users will be able to log in every time they need to report a test outcome.

Management will be given access to a platform in order to monitor and analyse data and review reports. Reports can include:

  • Positive/ Negative rate ratios by day, week or month
  • Exposure mapping to react promptly to outbreaks
  • Missed test reports

Full training will be provided to enable users to correctly carry out testing as well as user training for the reporting platform.

All data stored is done so compliance with Data Protection, GDPR and Confidentiality policies.

 
Panodyne Antigen and Influenza combo test kit

Antigen and Influenza
Combo Rapid Test Kit

Product Code: PDCA2T-U

Overview

Both COVID-19 and influenza A/B viruses (Flu A/B) can cause acute respiratory infections, and people are generally susceptible. These three viruses are highly contagious, spread quickly, have a short incubation period, and have a high incidence. Symptoms of COVID-19 and influenza may look similar, the main symptoms include.

With this combination test, healthcare workers can provide an accurate diagnosis to patients and treat them with the appropriate measures.

Benefits

  • Results ready in 15 minutes
  • Accurate diagnostic tool for active infection
  • Easy to administer and read results
  • Affordable, no need for instrument, highly portable
  • Enable testing on a massive scale
  • For healthcare workers use only

Contents

  • Sampling swab (nasopharyngeal swab)
  • Antigen extraction buffer
  • Antigen extraction tube and dropper tip
  • Paper workbench for 24 test kits (The one-test-box can be used as a workbench)
  • Instruction for use
  • Test kit

Intended Use

COVID-19 & FLU A/B Antigen Test Kit (Colloidal Gold) is used for in vitro qualitative detection of 2019 Novel Coronavirus antigen and influenza A/B antigen in human nasopharyngeal swab samples.

Product Information

Product:

SARS-CoV-2/FluA/FluB Antigen Test Kit (Colloidal Gold)

Pack formats:

1 Test/Box 24 Tests/Box

Test Type:

Antigen Test

Test Principle:

Colloidal Gold Method

Sample Type:

Nasopharyngeal Swab

Sample Volume:

3 Drops of Extracted Solution (about 100μl) Each Well

Qualitative / Quantitative:

Qualitative

Test Time:

15 Mins

Operation Temperature:

Room Temperature (15-30°C)

Storage Temperature:

Room Temperature or Refrigerated (2-30°C)

Shelf Life (Unopened):

24 Months


Storage and Stability

  • The test kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
  • Do not freeze.
  • Do not use beyond the expiration date.
  • After opening the sealed pouch, use the test as soon as possible within 60 minutes.

Specimen Collection

  • SARS-CoV-2/FluA/FluB Antigen Test kit (Colloidal Gold) can be performed using nasopharyngeal swab.
  • Testing should be performed immediately after specimen collection.
  • Bring specimens to room temperature prior to testing.
  • If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

Test Procedure

  1. Insert a swab through the nasal cavity to the nasopharynx of the patient, reaching the surface of the posterior nasopharynx when resistance is encountered.

  1. Gently rub and roll the swab for several seconds to absorb secretions.

  1. Slowly remove nasal swab while rotating it.

  1. Put the swab specimen into the antigen extraction tube pre-added with the antigen extraction buffer.
  2. Rotate the swab about 10 times while pressing the swab head against the tube wall to release the antigen in the swab.
  3. Let it stand for about 1 minute.
  4. Remove the swab while squeezing the tip of the swab so that as much liquid in the swab can be discharged as possible. Dispose of used swabs in accordance with biohazard waste disposal methods.
  5. Install the dripper on the antigen extraction tube and cap it tightly, and let it stand for about 1 minute.

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Place the test device on a clean and level surface. Transfer 3 drops (about 100μl) of the mixed liquid to each sample well of the test card (or use a pipette to add 100μl), and start the timer.

  1. Wait for the test result of the reagent. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

Interpretation of Result
Antigen and flu combo Interpretation of result
Antigen and flu combo Interpretation of result

For COVID-19 Antigen test kit:

Negative:

If only the C band is present, the absence of any burgundy colour in the T band indicates that no COVID-19 antigen is detected in the specimen. The result is negative.

Positive:

In addition to the presence of C band, if T band is developed, the test indicates for the presence of COVID-19 antigen in the specimen. The result is COVID-19 positive.

Invalid:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

For Flu A/B Antigen test kit:

Negative:

If only the C band is present, the absence of any burgundy colour in A and B bands indicates that no Flu A/B antigen is detected in the specimen. The result is negative.

Positive:

FLU A/B positive: In addition to the presence of the C-line, If the test lines A and B appears at the same time, it means that there are both influenza A virus antigen and influenza B virus antigen in the sample, that is, the result is positive for FLU A and FLU B.
FLU A positive: In addition to the presence of the C-line, if the test line A appears, the test indicates the presence of FLU A antigen in the sample, that is, the result is positive for FLU A.
FLU B positive: In addition to the presence of the C-line, if the test line B appears, the test indicates the presence of FLU B antigen in the sample, that is, the result is positive for FLU B.

Invalid:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Limitation

  1. Use fresh samples whenever possible.
  2. The COVID-19 and FLU A/B Antigen Test Kit will only indicate the presence of COVID-19/Influenza A/Influenza B Antigens in the specimen and should not be used as the sole basis for the diagnosis of COVID-19/Influenza A/Influenza B infections.
  3. Positive results do not rule out bacterial infection or co-infection with other viruses.
  4. A negative result for an individual subject indicates absence of detectable COVID-19 or Flu A/B antigen. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19 and Flu A/B.
  5. A negative result can occur if the quantity of the COVID-19 or Flu A/B antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19 or Flu A/B antigen in the nasal cavity of the patient.
  6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician combined with clinical observations, patient history, recent exposures and epidemiological information.
  7. The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper sample collection or storage.

Warnings and precautions

  1. Allow test cassette, antigen extraction buffer, specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
  2. For Professional In Vitro Diagnostic use only. Do not use after expiration date.
  3. These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All healthcare professionals have to read the instruction prior to performing a test.
  4. Do not use it if the tube/pouch is damaged or broken.
  5. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e., swab, extraction tube, test device) in a biohazard container as if they were infectious waste and dispose according to applicable local regulations.
  6. The provided swabs in the package should be used only for nasopharyngeal specimen collection.
  7. Test is for single use only. Do not re-use under any circumstances.
  8. Do not perform the test in a room with strong air flow, i.e., electric fan or strong air-conditioning.


Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Antigen and Influenza test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.

 
Panodyne Antigen Saliva test kit

Antigen Saliva Rapid Test Kit

Product Code: PDSTKA-U

Overview

Our Panodyne Antigen Saliva Test Kit is a user-friendly and non-invasive rapid test kit that can be self-administered under supervision by trained staff, healthcare professional, company nurse or occupational health personnel. It's also more comfortable and easier to use for vulnerable people or those with a disability.

Features

  • Results ready in 15 minutes
  • Non-invasive and user-friendly
  • Can be self-administered
  • Minimise discomfort, so easier for vulnerable and disabled people to use
  • Cost-effective for regular testing in the workplace
  • Quick and easy to read results
  • All you need is in the pack

Product Information
Product Name:

Panodyne SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold)

Pack Formats:

1 Test/Box 24 Tests/Box

Test Type:

Antigen Test

Test Principle:

Colloidal Gold Method

Sample Type:

Saliva

Sample Volume:

3 Drops of Extracted Solution (about 100μl) Each Well

Test Time:

15 Mins

Storage Temperature:

Room Temperature or Refrigerated (2-30°C)

Shelf Life (Unopened):

24 Months

Contents
COVID-19 Saliva Test kit contents
Test Procedure

  1. The test subject/person must spit carefully a quantity of saliva (2ml) from deep in the throat into the sample bag provided. The purpose is to obtain a quantity of saliva and avoid spraying saliva carelessly as with sneeze. Avoid any saliva contamination of the outer surface of the container.
  2. Open the test solution bottle, which has a twist off top. Pour the solution into the test tube provided.

  1. Use the pipette to take a sample of saliva from the sample bag.
  2. Transfer this sample to the test tube containing the test solution. Then place the test tube cap onto the test tube. Shake and mix completely.
  3. Carefully add 3 drops of the test sample liquid into the test cassette well marked "S". Wait for 15 minutes for the test result to develop in the cassette. If left unread for 20 minutes or more the results are invalid and a repeat test is recommended.

Interpretation of Result
Antigen and flu combo Interpretation of result
Antigen and flu combo Interpretation of result
Performance Characteristics

Antigen Test Cassette Results

PCR: Positive

PCR: Negative

Total Results

Antigen Test Cassette Positive

54

0

54

Antigen Test Cassette Negative

6

30

36

Total Results

60

30

90

Sensitivity and Specificity: the COVID-19 Antigen Test Cassette was compared with a commercial PCR and the results show a high sensitivity and specificity.

Relative Sensitivity: 90.00% (95%CI: 79.49-96.24%)
Relative Specificity: 100.00% (95%CI: 88.43-100.00%)
Accuracy: 93.33% (95%CI: 86.05-97.51%)

Limitations

  1. This test detects both viable (live) and non-viable, SARS-CoV and COVID-19. Test performance depends on the amount of virus (antigen) in the sample and may or may not be correlated with viral culture results performed on the same sample.
  2. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
  3. The performance of COVID-19 Antigen Test Cassette was evaluated using the procedures provided in this product insert only. Modifications to these procedures may alter the performance of the test.
  4. False negative results may occur if a specimen is improperly collected, transported, or handled.
  5. If the test is performed more than 1 hour after the specimen is collected, false results may occur. The specimen should be tested as soon as possible after specimen collection.
  6. Positive test results do not rule out co-infections with other pathogens.
  7. Positive test results do not differentiate between SARS-CoV and COVID-19.
  8. Negative test results are not intended to rule out other non-SARS viral or bacterial infections.
  9. Negative results from patients with symptom onset beyond seven days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed.
  10. If the differentiation of specific COVID-19 viruses and strains was needed, additional testing, in consultation with state or local public health departments is required.


Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Saliva test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.

 
Panodyne Neutralising Test Kit

Neutralising Antibody Rapid Test Kit

Product Code: PDNVAT-U

Test Kit for COVID-19 diagnosis and vaccine evaluation

This kit is used for the in vitro qualitative determination of Neutralising Antibodies concentration in human serum/plasma or whole blood samples.

Neutralising antibody (NAb) is a naturally-produced antibody as part of the immune system's response. These antibodies inhibit or destroy the influence of foreign factors that invade the body. Neutralising antibodies can be triggered by infection or vaccination, produced by B lymphocytes, and bind to antigens on the surface of pathogenic microorganisms, thereby preventing the pathogenic microorganisms from adhering to target cell receptors and preventing cell invasion.

Distinguish the neutralising antibody-binding antibody
Distinguish the neutralising antibody-binding antibody
Product Information
Application scenarios:

Assess the body's immunity to the COVID-19 and the effectiveness of the COVID-19 vaccine. (Detects the presence of neutralising antibodies).

Method:

Colloidal gold

Sample:

Whole blood, serum, or plasma

Sensitivity:

94.17%

Specificity:

98.18%

Storage:

Cool, dark and dry place at 2-30°C (Do not freeze)

Shelf-life:

24 Months

Packaging specification:

24 cassette/box

Time to report:

15 minutes

 
Panodyne Antibody Test Kit

Antibody Rapid Test Kit

Product Code: PDCTKCT-U

Antibody Rapid Test Kit

COVID-19, it is a novel coronavirus with new strain that has not been previously identified in humans, belongs to Coronaviruses (CoV) such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

Specification

  • Sample Volume: 10μl
  • Fast Reaction: 15 minutes
  • For professional use only

Product name
Specimen
Format
Kit size

SARS-CoV-2 IgM/IgG Ab Rapid Test

WB/S/P

Cassette

24 Tests/kit

Intended Use

Used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

Performance

Sensitivity:

94.15%

Specificity:

93.91%

Total consistent:

94%

Note: Results compared to Molecular testing.

Test procedure and Read result

Serum/Plasma

  1. Add 10μl of serum or plasma vertically into the sample well.
  2. Add two drops (70μl) of sample buffer into the sample well.
  3. Read results within 10~15 minutes, the result is invalid over 20 minutes.

Whole Blood

  1. Add 10μl of whole blood vertically into the sample well.
  2. Add two drops (70μl) of sample buffer into the sample well.
  3. Read results within 10~15 minutes, the result is invalid over 20 minutes.

Organisations and businesses who already are or wish to implement a test tracking program, please click on the link below to download the Panodyne COVID-19 Antibody Test declaration form for subjects to sign and for your records. The declaration form can be used for research and consent form purposes only.

Why do we need Antigen and Antibody tests for COVID-19?

COVID-19 testing
Viral Diagnostics: A Quick Recap

The two major methods for diagnosing viral infection are the polymerase chain reaction (PCR), and immunoassays:

The case for less sensitive COVID tests

Watch the video below to find out how cheap, fast, and less sensitive rapid antigen tests might be better for screening (and maybe surveillance) than PCR COVID tests due to the nature of contagiousness/infectiveness at various points on the viral load trajectory of symptomatic and asymptomatic COVID Sars-COV-2 carriers.

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