Testsealabs – COVID-19 Professional Rapid Test Kits

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.

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%)

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

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