Testsealabs – COVID-19 Professional Rapid Test Kits

Buy Testsealabs covid antigen test kit online at OdemShop. With our Testsealabs rapid test kit, you can quickly and reliably detect COVID-19 infections.

1,75 €*

Content: 25 Stück (0,07 €* / 1 Stück)

Available, delivery time 5 - 7 Working days

Product information "Testsealabs – COVID-19 Professional Rapid Test Kits"

Buy Testsealabs COVID Test Kit


With our Testsealabs Rapid Test Kit, you can quickly and reliably detect COVID-19 infections. Thanks to a high sensitivity of 92.10% and a specificity of 98.10%, the test offers excellent accuracy. The three possible sampling methods (anterior nasal, nasopharyngeal, oropharyngeal) offer flexible and individually tailored sampling.


Testsealabs COVID Test Kit 3-in-1 Rapid Tests

✓ BfArM listed, test ID: AT082/20
✓ Evaluated by the Paul-Ehrlich-Institut
✓ Listed on the Common RAT List of the HSC, Device ID: 1392
✓ Can detect Delta and Omicron variants
✓ Test results readable after 15 minutes
✓ All materials included in delivery
✓ Flexible and location-independent
✓ For medical personnel only

Our tests are all CE-certified and suitable for use in the European market.


Delivery Contents of the Testsealabs COVID Test Kit

25 sterile swabs
25 test cassettes
25 extraction tubes
1 tube stand
1 user manual

Order now and quickly, reliably and easily detect COVID-19 with the Testsealabs antigen test set!


Why Buy the Testsealabs COVID Test Kit?

✓ MONEY-BACK GUARANTEE

Our goal is your satisfaction with your purchase. If the purchased product does not meet your expectations, you can return it within the 14-day cancellation period and receive a refund of the purchase price.


Comparison - Professional COVID-19 Antigen Rapid Tests
Manufactured by Hecin Testsealabs Bioteke Longsee Green Spring Roche Siemens
Sensitivity 97.09% 92.10% 96.49% 95.51% 96.77% 96.52% 97.25%
Specificity 99.78% 98.10% 99.28% 99.72% 100% 99.60% 100%
Manufactured in China China China China China South Korea China
Listed for the
"EU common list"
Yes, in category A Yes Yes Yes, in category A Yes Yes Yes

Frequently Asked Questions about Testsealabs COVID Test Kit

What is a Testsealabs COVID Test Kit Antigen Test?

A Testsealabs SARS-CoV-2 Antigen Rapid Test is a professional, on-site antigen test for COVID-19 that directly detects the pathogen and its antigens. The test consists of a swab from the back of the nose or throat and a test cassette that works according to the lateral flow principle. In a time frame of 10-15 minutes, it is possible to determine the presence of COVID-19 antigens in the sample. The test consists of 25 test cassettes, swabs, extraction tubes, and buffer doses. It is intended for professional use and must be brought to room temperature before use.


Can the Testsealabs Rapid Test Kit detect mutations?

Yes, the Testsealabs SARS-CoV-2 Antigen Rapid Test Kit can detect, among others, the Delta and Omicron variants.


Is the Testsealabs Antigen Test Kit safe?

Yes, the sensitivity of the test is 92.10% and the specificity is 98.10%. As the test is on the "Common List" (list of the European Commission), the test is considered safe throughout Europe.
In addition, the Testsealabs SARS-CoV-2 Ag Rapid Test Kit has been evaluated by the PEI.


How does the Testsealabs Antigen Test Kit work?

Through nasopharyngeal or oropharyngeal sample collection.


How long does it take to get the result of the Testsealabs Antigen Rapid Test?

15 minutes.


How is the professional Testsealabs SARS-CoV-2 Ag Rapid Test packaged?

There are 25 tests in one box, and 750 in a whole carton.


How long is the professional Testsealabs Covid-19 Antigen Rapid Test shelf life?

Stable at room temperature or between 4 and 35 degrees for up to 12 months.


Does the Testsealabs SARS-CoV-2 Antigen Rapid Test Kit detect the Omicron variant?

Yes, the Testsealabs COVID-19 Ag tests have been tested by the Paul-Ehrlich-Institut. The Omicron variant is fully detected.


How did the tests perform on the Paul-Ehrlich-Institut's control list?

The tests are on the list that meets the sensitivity criteria. You can read the details here.


Who is allowed to use the tests?

These tests are exclusively for professional use. Lay antigen tests can be found here.


How did the tests perform on the Paul-Ehrlich-Institut's checklist?

The list contains tests that meet the sensitivity criteria and are in the top 20% of the list. You can read the exact details here.


Where can I find more information about antigen tests?

For extensive information on antigen tests, you can consult our information center.


Where can I find the instructions for the Testsealabs Rapid Test Kit antigen test?

You can find the instructions here.

Specifications Testsealabs

Pack
Packs of 25


Carton
30 boxes - Total: 750 tests


Standards and market conformity

Professional use (distribution to professional users only)

Rapid test 3 in 1

Approved in Germany

TÜV South EN ISO 13485:2016

BFarm number: AT082 / 20

This test is included in the Federal Institute for Drugs and Medical Devices list under the regulation on coronavirus testing (TestV). It has been certified with a CE mark and is eligible for cost reimbursement.

92.10% sensitivity - 98.10% specificity

With integrated buffer solution

A guide for using the Testsealabs Professional Antigen Rapid Test

Instructions for the Testsealabs Professional Rapid Antigen Tests

Testsealabs Covid-19 Antigen (SARS-CoV-2) Rapid Test Cassette (Swab)

Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal, oropharyngeal and nasal swabs. For professional use in in-vitro diagnostics


Intended use

The COVID-19 Antigen Rapid Test Cassette is a chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal, oropharyngeal and nasal swabs to aid in the diagnosis of SARS-CoV-2 virus infection.


Overview

The COVID-19 antigen rapid test cassette is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2-N antigen in nasopharyngeal, oropharyngeal and nasal swabs. In this assay, an anti-SARS-CoV-2-N antibody is immobilised in the test zone of the membrane. After a swab sample is placed in the sample window, it reacts with anti-SARS-CoV-2-N antibody-coated particles located on the sample pad. This mixture migrates chromatographically along the length of the test membrane and interacts with the immobilised anti-SARS-CoV-2-N antibodies.

If the sample contains SARS-CoV-2 antigen, a coloured line appears in the test zone, indicating a positive result. If the sample does not contain SARS-CoV-2 antigen, no coloured line appears in this area, indicating a negative result. As a procedural control, a coloured line always appears in the control zone area, indicating that the correct sample volume has been added and the membrane has been wetted through.


Reagents

The test contains an anti-SARS-CoV-2-N antibody as capture reagent and another anti-SARS-CoV-2-N antibody as detection reagent. A goat anti-mouse antibody is used in the control line system.


Safety precautions

• For professional in vitro diagnostic use only. Do not use after the expiry date.

• Make sure that the foil pouch containing the test cassette is not damaged before opening it for use.

• Wear gloves and personal protective equipment when taking and applying the samples. Do not touch the reagent membrane and the sample window. - Do not eat, drink or smoke in the area where the samples and kits are handled.

• Handle all samples as if they contain infectious agents.

• In all procedures, observe the established precautions and regulations when working with biological hazards and follow the regulations for the proper disposal of samples.

• Carry out the test at a room temperature of 15 - 30 °C.


Storage and stability

Store at room temperature or refrigerated (4-30°C). Do not freeze. The test is stable until the expiry date printed on the sealed pouch. Do not use after the expiry date. The test must remain in the sealed pouch until use.


Sampling and preparation

The COVID-19 Antigen Rapid Test is designed for use with nasopharyngeal, oropharyngeal and nasal swabs. Have a medically trained person perform the swab. For the best possible results, it is recommended that a nasopharyngeal swab be performed


Instructions for performing as a nasopharyngeal swab

Pass the swab over the nose into the nasopharynx and swab the nasopharynx in 2-3 circular motions.


Instructions for carrying out as a nasal swab

Insert the entire tip of the swab two to three centimetres into the left nostril. Rub the inside of the nostril in a circular motion for at least 15 seconds. Remove the swab and insert it into the right nostril. Swab the inside of the nostril in a circular motion for at least 15 seconds.


General information

Do not return the swab to its original paper packaging. For best results, swabs should be tested immediately after collection. If immediate testing is not possible, to maintain the best possible performance and to avoid possible contamination, it is strongly recommended that the swab is placed in a clean, unused plastic tube labelled with patient information. The sample can be kept tightly sealed in this at room temperature (15-30°C) for a maximum of one hour. Make sure that the swab is firmly seated in the tube and the cap is tightly closed. If there is a delay of more than one hour, discard the sample. A new sample must be taken for the test.

If specimens are to be transported, they should be packaged according to local regulations for the transport of aetiological agents.


Materials

Provided materials:

Test device extraction tube with sample buffer

User manual Sterile swab Tube stand


Required - but not included - materials:
Timer


Instructions for use

Allow the test, sample, and buffer to reach room temperature 15-30°C (59-86°F) before performing the test.

1-Place the extraction tube in the workstation.

2-Peel off the aluminum foil seal from the top of the extraction tube containing the extraction buffer.

3-Have a medically trained person perform the nasopharyngeal, oropharyngeal, or nasal swab as described.

4-Insert the swab into the extraction tube. Turn the swab for about 10 seconds.

5-Remove the swab by turning it against the extraction tube while squeezing the sides of the tube to release the liquid from the swab. Dispose of the swab properly. While pressing the head of the swab against the inside of the extraction tube to remove as much liquid as possible from the swab.

6-Close the bottle with the supplied cap and press it tightly onto the bottle.

7-Mix thoroughly by inverting the bottom of the tube. Add 3 drops of the sample vertically into the sample window of the test cassette. Read the result after 10-15 minutes. Read the result within 20 minutes. Otherwise, repeat the test.


Interpretation of results


Positive:
Two red lines appear. One red line appears in the control zone (C) and one red line appears in the test zone (T). The test is considered positive even if only a faint line appears. The intensity of the test line may vary depending on the concentration of SARS-CoV-2 antigens present in the sample.


Negative:
Only one red line appears in the control zone (C), and no line appears in the test zone (T). The negative result indicates that no SARS-CoV-2 antigens are present in the sample or that the concentration of antigens is below the detection limit.


Invalid:
No red line appears in the control zone (C). The test is invalid even if a line appears in the test zone (T). Insufficient sample volume or incorrect handling are the most likely reasons for failure. Verify the test procedure and repeat the test with a new test cassette.

testsealabs instruction

Quality Control

The test contains an internal procedural control in the form of a colored line appearing in the control zone (C), which confirms sufficient sample volume and correct handling. Control standards are not provided with this kit. However, it is recommended to test positive and negative controls as good laboratory practice to confirm the test procedure and verify proper test performance.


Limitations

• This test detects both replicating and non-replicating SARS-CoV-2 viruses. Test performance depends on the amount of virus (its antigen) in the sample and may or may not correlate with the results of virus culture performed on the same sample.

• A negative test result may occur when the antigen concentration in a sample is below the limit of detection of the test. The limit of detection of the test was determined with recombinant SARS-CoV-2 nucleocapsid protein and was 100 pg/ml.

• The performance of the SARS-CoV-2 antigen test cassette has been evaluated solely with the procedures described in this package insert. Changes to these procedures may alter the performance of the test.

• False-negative results may occur when a sample is improperly collected, transported, or handled.

• False results may occur when samples are tested later than one hour after collection. Samples should be tested as soon as possible after collection.

• Positive test results do not exclude co-infection with other pathogens.

• Negative test results are not intended to make statements about other viral or bacterial infections other than SARS-CoV-2.

• Negative results from patients with symptom onset after more than seven days should be treated as presumptive and confirmed with another molecular assay.

• If differentiation of specific SARS-CoV-2 strains is required, additional tests are necessary in consultation with state or local health authorities.

• Children may tend to shed viruses longer than adults, which can lead to different sensitivity between adults and children and make comparisons more difficult.



Performance Characteristics

Limit of Detection: The limit of detection of the test was determined using infectious SARS-CoV-2 virus and is 50 x TCID50.


Clinical Parameters Nasopharyngeal Swab

To determine sensitivity and specificity, the COVID-19 antigen rapid test cassette was compared to a commercial PCR test using nasopharyngeal swabs.



Sensitivity Specificity
97.6% 95% CI: (94.9%-100%) 98.4% 95%Cl: (96.9%-99.9%)


Determination of Specificity


Number of Samples PCR Negative COVID-19 Antigen Rapid Test
250 250 247/250 = 98.8%
Total 250 247/250 = 98.8%
95%Cl: (98.5%-99.1

Determination of Sensitivity


Days after Symptom Onset Number of Samples PCR Negative COVID-19 Antigen Rapid Test
1 3 3 3/3=100%
2 9 9 9/9=100%
3 14 14 14/14=100%
4 17 17 17/17=100%
5 22 21 21/22=95.4%
6 26 26 25/26=96.1%
7 34 34 33/34= 97.0%
Total 125 125 122/125=97.6%
95% CI: (94.9%-100%)
Sensitivity Specificity
97.6% 95% CI: (94.9%-100%) 98.4% 95%Cl: (96.9%-99.9%)


Determination of Specificity


Number of Samples PCR Negative COVID-19 Antigen Rapid Test
250 250 247/250 = 98.8%
Total 250 247/250 = 98.8%
95%Cl: (98.5%-99.1

Determination of Sensitivity


Days after Symptom Onset Number of Samples PCR Negative COVID-19 Antigen Rapid Test
1 3 3 3/3=100%
2 9 9 9/9=100%
3 14 14 14/14=100%
4 17 17 17/17=100%
5 22 21 21/22=95.4%
6 26 26 25/26=96.1%
7 34 34 33/34= 97.0%
Total 125 125 122/125=97.6%
95% CI: (94.9%-100%)

Clinical parameters Nasal swab


To determine sensitivity and specificity, the COVID-19 antigen rapid test case was compared with a commercial PCR test. sette with nasal swabs was compared with a commercial PCR test. All swabs were were performed by the patients themselves, and the results were reported by the patients.


Sensitivity Specificity
93.6% 95% CI: (92.5%-94.7%) 98.8% 95% Cl: (98.5%-99.1%)

Determination of the specificity


Number of samples PCR negative COVID-19 antigen string test
250 250 247/250 = 98.8%
Total 250 247/250 = 98.8%
95%Cl: (98.5%-99.1%)

Determination of the sensitivity


Days after onset of symptoms Number of samples PCR negative COVID-19 antigen string test
1 3 3 3/3=100%
2 9 9 9/9=100%
3 14 14 14/14=100%
4 17 17 17/17=100%
5 22 21 21/22=95.4%
6 26 26 24/26=92.3%
7 34 34 29 /34= 87.8%
Total 125 125 117/125=93.6%
95% CI: (92.5%-94.7%)
testsealabs instruction

Cross-reaction: The COVID-19 antigen rapid test cassette has been tested for specificity and cross-reactivity with other pathogens that may cause similar symptoms. The results showed no cross-reactivity.


Pseudomonas aeruginosa Concentration
Pseudomonas aeruginosa 1x108 Zellen/mL
Streptococcus sp group F 1x108 Zellen/mL
Streptococcus salivarius 1x108 Zellen/mL
Streptococcus pygenes 1x108 Zellen/mL
Streptococcus pneumoniae 1x108 Zellen/mL
Staphylococcus epidermidis 1x108 Zellen/mL
Staphylococcus aur. subspaureus 1x108 Zellen/mL
Nesseria subllava 1x108 Zellen/mL
Neisseria lactamica 1x108 Zellen/mL
Moraxella catarrhalis 1x108 Zellen/mL
Escherichia coli 1x108 Zellen/mL
Corynebacterium 1x108 Zellen/mL
Candida albicans 1x108 Zellen/mL
Arcanobacterium 1x108 Zellen/mL
Human Coronavirus OC43 2.45x106 LD50/ml
Human Coronavirus NL63 1.17x105U/mL
Influenza A H1N1 3.16x105 TCID50/ml
Influenza A H3N2 1x106 TCID5050/ml
Influenza B 3.16x106 TCID5050/ml
Human Rhinovirus 2 2.81x104 TCID5050/ml
Human Rhinovirus 14 1.58x106 TCID5050/ml
Human Rhinovirus 16 8.89x106 TCID5050/ml
Masern 1.58x104 TCID5050/ml
Mumps 1.58x104 TCID5050/ml
Parainfluenza Virus 2 1.58x104 TCID5050/ml
Parainfluenza Virus 3 1.58x104 TCID5050/ml
Respiratorisches Syncytial-Virus 8.89x104 TCID5050/ml


Interfering substances:
 The following compounds were tested with the COVID-19 antigen rapid test and no interferences were observed.


Substance Concentration Substance Concentration
Whole blood 20 μl/ml Mupirocin 12 mg/ml
Mucus 50 μl/ml Oxymetazoline 0.6 mg/ml
Budesonide Nasal Spray 200 μl/ml Phenylephrine 12 mg/ml
Dexamethasone 0.8 mg/ml Rebetol 4.5 μl/ml
Flunisolide 6.8 ng/ml Relenza 282 ng/ml

You can download these instructions here download

testsealabs instruction

Importeur:


Better AG
General-Guisan-Str. 8
6300 Zug
Switzerland
CH: + 41 (0) 71 58 80 248

E-Mail: info@OdemShop.ie

Web: www.OdemShop.ie

General FAQ

How does Odem ensure high quality at such a fair price?

The Better AG, founded in 2006 in Switzerland, has become the main supplier for thousands of companies in recent years.

The strategy:

• Bulk purchasing

• Close quality control of the goods

• Passing on the purchasing advantages to our customers

• By offering the possibility to receive free samples, our customers are not taking any risks.


What is the money-back guarantee?

If you are not satisfied with your goods, you can return them within 14 days of purchase and receive a full refund.


What payment options are available?

We offer a convenient payment by invoice after receipt of the goods to a German bank account.


Has the goods already been cleared through customs?

Yes, the goods have already been cleared through customs and will be delivered to you from our German warehouse. You will not incur any additional costs.

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