A user guide for Antigen and Antibody Rapid Test Kits

How to take Panodyne antigen covid test

Antigen Rapid Test Kit Test Procedure and Interpretation

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

1. Nasopharyngeal swab collection method:

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.

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Slowly penetrate nasal cavity

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.

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Keep the swab in place for 3 seconds then gently rotate the swab

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.
Picture of how to take a Throat sample using a Panodyne Antigen swab test kit

Wipe the tonsils on both sides

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.

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Lateral Flow Device (LFD) cassette Test interpretation of results

Once 10-15 minutes has passed check the results indicator

The “C” (control) line must have a red mark or the test is invalid

The “T” (test) line is red for a positive result (even a faint line is a positive result)

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Lateral Flow Device (LFD) cassette test ordering Information

Description:SARS-CoV-2 Antigen Rapid Test
Time to result:15 minutes
Product No:PDRTKTA-U
Format:Cassette
Kit size:1 Tests / kit
covid antigen test


Organisations and businesses who already are or wish to implement a rapid antigen 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.


Explainer Video of Antigen Rapid Test Kit


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

Antigen Saliva Rapid Test Kit

Product Code: PDSTKA-U

Overview

Our Panodyne Antigen Saliva Test Kit (Lateral Flow Device) 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.

Rapid Antigen Test 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

PPanodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit
Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit
Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit
Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit

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 carelessly as with a sneeze. Avoid any saliva contamination of the outer surface of the container. Optimal timing of the specimen colleciton is after getting up before you brush your teeth and eat or drink anything

Test Procedure

Split carefully into the sample bag, then pour the test solution into the test tube

1. Open the test solution bottle and pour the solution into the test tube provided

2. Use the pipette to take a sample of saliva and transfer this to the test tube containing the solution. Replace the cap on the test tube and shake to mix completely

3. Carefully add 3 drops of the test sample into the test cassette well marked “S” and wait for 10 – 15 minutes. If left unread for 20 minutes or more the results are invalid

Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit

Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit

Panodyne COVID-19 Antigen (Saliva) Rapid Lateral Flow Test Kit

Take a sample from the sample bag using the pipette, transfer the sample to the test tube containing the solution. Replace top and shake well. Add 3 drops from the test tube mixture into sample well of the cassette.

Once 10-15 minutes has passed check the results indicator

The “C” (control) line must have a red mark or the test is invalid

The “T” (test) line is red for a positive result (even a faint line is a positive result)

Explainer Video of the Rapid Antigen Saliva Test

Interpretation of Result

Performance Characteristics

Antigen Test Cassette ResultsPCR: PositivePCR: NegativeTotal Results
Antigen Test Cassette Positive54054
Antigen Test Cassette Negative63036
Total Results603090

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 COVID-19 RAPID ANTIGEN (SALIVA) TEST KIT CE

Neutralising Antibody Rapid Test Kit

Product Code: PDNVAT-U

Test Kit for COVID-19 diagnosis and vaccine evaluation
Post-Vaccine Immunisation Tests (Blood)

The Panodyne COVID-19 IgM/IgG/Neutralising Antibody Rapid Test Kit (blood sample), which has gained CE certification, is intended for Professional Use to help assess the body’s immunity to COVID-19 (SARS-CoV-2) and effectiveness of the COVID-19 vaccine at the time of testing.

It’s quick and accurate. The point of care test uses a whole blood, serum, or plasma sample to detect the presence of neutralising antibodies, and a positive or negative result is visible within 15 minutes of testing.

Each individual test kit includes 1x test cassette, 1x lancet, 1x buffer, 1x alcohol wipe, 1x results check card, 1x dropper pipette, 1x instructions, which are all located inside a sealed test kit wallet.

The test kit works very quickly, is easy to use, and test results are easy to read. Also, please note that if you are experiencing any COVID-19 symptoms, you must follow Government guidelines in terms of isolating and testing.

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.

A recent article was published on the National Health Executive website about Panodyne tests which can be read here.

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

PDNVAT-U-Neutralising-Antibody-Test-Kit-24-box

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
PDNVAT-U-Neutralising-Antibody-Test-kit-wallet

Explainer video of the Panodyne Neutralising Antibody Rapid 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
SARS-CoV-2 IgM/IgG Ab Rapid TestWB/S/PCassette24 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.

Explainer Video of the Antibody Rapid Test Kit

Panodyne Antibody test kit covid antigen test

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.

Add to the sample well using the pipette, then add two drops of buffer to the sample well.

Wait 10 or 15 minutes for the results

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Once 10-15 minutes has passed check the results indicator

The “C” (control) line must have a red mark or the test is invalid

The “T1” line is red – you have recently had COVID-19 and your body has produced new antibodies to fight the virus.

The “T2” line is red – you have had COVID-19 and your body has produced antibodies to fight the virus.

The “T1” & “T2” lines are red – you are in the latter stages of COVID-19 and are currently fighting off the virus.

Antigen and Influenza
Combo Rapid Test Kit

Product Code: PDCA2T-U

Antigen and Influenza
Combo Rapid Test Kit

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

Testing made easy with the test kit tube stand workbench


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.

Antigen and Influenza Combo Rapid Test Kit Test Procedure

1

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

2

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

3

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

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

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

Slowly remove nasal swab while rotating it.

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
Picture of how to take a nasal sample using a Panodyne Antigen swab test kit
  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.

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.

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

Picture of how to take a nasal sample using a Panodyne Antigen swab test kit

Explainer video of the Panodyne Antigen and Influenza Combo Rapid Test Kit

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.

Rapid Fire Supplies

2430 / 2440 The Quadrant, Aztec West,
Almondsbury,
Bristol, Sth. Gloucestershire BS32 4AQ
Phone: 03330150330
Additional phone number: 01275 545472
Email: cs@rapidfiresupplies.co.uk
Monday8:30 AM - 7:00 PM
Tuesday8:30 AM - 7:00 PM
Wednesday8:30 AM - 7:00 PM
Thursday8:30 AM - 7:00 PM
Friday8:30 AM - 7:00 PM
Saturday9:00 AM - 5:00 PM
SundayClosed

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