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Testsealabs rapid test for diagnosing coronavirus infection SARS-CoV-2 Covid-19 No. 1
SKU: an-1056680
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458.56 грн.
Country of manufacture:China
Form:Covid-19 coronavirus test
Producer:Hangzhou Testsie Biotechnology
Quantity per package:1 pc
Trade name:Testsealabs
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Testsealabs rapid test for diagnosing coronavirus infection SARS-CoV-2 Covid-19 No. 1
458.56 грн.
Description
The packaging marking and instructions contain the designation of SI units, in accordance with the requirements of the Order of the Ministry of Economic Development and Trade of Ukraine dated 04.08.2015 No. 914 in the Ukrainian version and the international version. The latter is indicated in brackets – ( ), next to the Ukrainian version:
Name
Marking
Name
Marking
microliter/milliliter
μl/ml (μl/ml)
minute
min
microgram/milliliter
micrograms/ml (μg/ml)
second
with (s)
milligram/milliliter
mg/ml (mg/ml)
centimeter
cm (cm)
nanogram/milliliter
ng/ml (ng/ml)
units/milliliter
Units/ml (U/ml)
picogram/milliliter
pg/ml (pg/ml)
colony forming units/milliliter
CFU/ml (org/ml)
hour
hour (h)
APPOINTMENT
The COVID-19 Virus Antigen Rapid Test is a rapid immunochromatographic assay for the qualitative detection of SARS-CoV-2 (COVID-19) virus antigen in a nasopharyngeal swab specimen to facilitate the diagnosis of COVID-19 viral infection and is intended for self-testing.
The rapid test for determining the antigen of the COVID-19 virus allows you to recognize the following virus strains: "British" (VOC-202012/01, B.1.1.7 or 20B/501Y.V1), with 4 mutations in the nucleoprotein located at the DЗL, R203K, G203R and S235F sites; "South African" (501.V2, 20C/501Y.V2 or B.1.351), does not contain any mutations in the nucleoprotein; "Brazilian" and "Indian" (P.1, B.1.617.1 and B.1.617.2), mutations in the nucleoprotein are located at the P6T, P13L and S33I sites, and "omicron" (B.1.1.529), mutations are located in a part called the spike protein on the surface of the virus.
The rapid test for the detection of COVID-19 virus antigen is produced using nucleoprotein monoclonal antibodies to detect and recognize epitopes whose corresponding antigens are located in the N47-A173 regions (NTD regions).
Nucleocapsid phosphoprotein
PRINCIPLE OF OPERATION
The COVID-19 Rapid Antigen Test is a qualitative immunoassay based on a chromatographic immunological membrane reaction for the detection of SARS-CoV-2 (COVID-19) virus antigen in a nasopharyngeal swab specimen. In this assay, the swab specimen is placed in a specimen well where it reacts with anti-COVID-19-N antibody-coated particles contained in the test strip pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-COVID-19 antibody.
If the specimen contains SARS-CoV-2 (COVID-19) antigen, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain SARS-CoV-2 (COVID-19) antigen, no colored line will appear in this region, indicating a negative result. As an internal control, a colored line will always appear in the control line region, indicating that there is sufficient sample volume and that the membrane has absorbed it.
REAGENTS
This test contains one anti-COVID-19-N antibody as a capture reagent and another anti-COVID-19-N antibody as a detection reagent. Goat anti-mouse IgG antibodies are used in the control line system.
Reservation
SAFETY MEASURES
For in vitro diagnostic use only.
Do not use after the expiration date.
Before beginning the test, it is important to carefully read the testing and interpretation instructions. Specimen collection is critical to the performance of the test. Failure to follow these procedures may result in inaccurate results.
Do not use the test if the integrity of the packaging is damaged.
All specimens should be handled as if they contain infectious agents.
Follow established precautions regarding microbiological hazards during all procedures, as well as proper disposal, namely: dispose of the test and used components in a tightly sealed plastic bag in a waste container.
Use disposable gloves when handling samples.
If a third party collects the sample, they should read the testing instructions and wear disposable gloves and a disposable mask before beginning the sample collection procedure.
Please note that excessive humidity and temperatures outside the range of +4 °C to +30 °C may negatively affect the analysis results.
Storage conditions
STORAGE AND STABILITY
The tests should be stored in their sealed packaging, at room temperature or in a refrigerator (at temperatures between +4 °C and +30 °C). The test is stable until the expiration date indicated on the sealed packaging. The test should remain in its sealed packaging until used.
DO NOT FREEZE. Do not use the test after the expiration date. Store in a dry place. Protect from sunlight.
Method of application
SPECIMEN COLLECTION AND PREPARATION
1. The rapid test for the detection of COVID-19 virus antigen (immunochromatographic assay) is used for the analysis of a nasopharyngeal swab and is intended for self-monitoring.
2. Sequence of material collection:
1) Estimate the distance between the nostrils and the opening of the external auditory canal, subtract 1-2 centimeters (cm) - this is the approximate depth to which the nasopharyngeal swab should be inserted.
3) Before handling the swab, put on disposable gloves. Do not use gloves if their packaging has been damaged.
4) Insert the swab into the nostril with a light movement along the outer wall of the nasal passage to a depth of 2-3 cm (cm) from the nasal opening, insert the swab into the nostril parallel to the palate, to the inferior turbinate, then slightly lower the swab down, insert into the lower nasal passage under the inferior turbinate by approximately 3-4 cm (cm) in children, 5-6 cm (cm) in adults. If the swab cannot be inserted to the appropriate depth (curvature of the nasal septum, other anatomical features, etc.), repeat the attempt through the other nostril.
5) Having reached the measured distance, leave the swab for 2-3 seconds (s) to allow the mucous secretions to be absorbed, then remove it from the nasal cavity along its outer wall simultaneously with rotational movements.
CAUTION: Do not let go of the nasopharyngeal swab during manipulations in the nostrils to prevent injury, inhalation of the swab, and its entry into the sinuses.
6) If the swab is sufficiently saturated with secretions, it is not necessary to collect from the second nostril. If necessary, samples from both halves of the nose can be collected with one swab.
3. Do not return the nasopharyngeal swab specimen collection back to the original paper packaging.
4. To obtain a reliable result, the sample should be tested as soon as possible after collection from the nasopharynx. If immediate testing is not possible, then to maintain the reliability of the indicators and avoid possible contamination of the sample, it is recommended to place the nasopharyngeal swab in a clean, previously unused plastic tube, preserving the integrity of the sample. The tube should be tightly closed and stored at room temperature (+15 °C to +30 °C) for 1 hour (h) before testing. It should be ensured that the swab fits securely in the tube and the cap is tightly closed. If the delay before testing exceeds 1 hour (h), the sample should be disposed of in a tightly closed plastic bag, in a waste container. A new sample should be taken for analysis.
5. If specimens need to be transported, they should be packaged in accordance with local regulations for the transport of etiological agents.
MATERIALS
Package contents (number of sets indicated on the box): test cassette, extraction tube with buffer, nasopharyngeal swab, instructions for use.
Before performing the analysis, wait until the test, sample, buffer and/or controls have reached room temperature (+15 °C to +30 °C).
1. Place the swab with the sample in the buffer in the extraction tube. Rotate the swab for approximately 10 seconds (s) while pressing its head against the inside wall of the tube to release the antigen.
2. Remove the swab by squeezing the head inside the extraction tube. As you remove, squeeze as much liquid as possible from the swab. Dispose of the used swab according to the user’s biohazard waste disposal protocol.
3. Close the tube with the cap, and then, holding it vertically, apply 3 drops of the sample to the sample well (in the extraction tube from the single-test kit, unscrew the white cap beforehand).
4. Check the result after 10-15 minutes (min). If the result is not read after 20 minutes (min) or longer, it is considered invalid and retesting is recommended.
INTERPRETATION OF RESULTS
Positive: Two lines appear. One should always appear in the control line region (C), the other should appear in the test line region.
*NOTE: The intensity of the color in the test line region may vary depending on the concentration of SARS-CoV-2 (COVID-19) virus antigen present in the specimen.
Accordingly, any shade of color in the test line area should be considered positive.
Negative: One colored line appeared in the control line region (C). No visible colored line appeared in the test line region.
Invalid: Control line not visible. Insufficient specimen volume or incorrect technique are the most likely causes of a missing control line. Review the procedure and repeat the test using a new product. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.
DO NOT MAKE ANY MEDICAL DECISIONS BASED ON THE TEST RESULT WITHOUT CONSULTING A DOCTOR!
QUALITY CONTROL
The test includes an internal control of the procedure.
The colored line that appears in the control region (C) is the internal control of the procedure. It indicates that the specimen volume is adequate and the technique used is correct. Control standards are not included in the kit; however, it is recommended that positive and negative control tests be performed as part of good laboratory practice to confirm the test procedure and verify proper test performance.
LIMITATION
This test detects both viable (live) and non-viable SARS-CoV and SARS-CoV-2 viruses. The performance of the test depends on the amount of virus (antigen) in the sample and may or may not correlate with results obtained after virus isolation from the same sample.
The performance of the COVID-19 Rapid Antigen Test has been evaluated using only the procedures outlined in this product instruction for use. Changes to these procedures may affect the performance of the test.
False negative results can occur if the sample is collected incorrectly.
Erroneous results may occur if samples are analyzed more than 1 hour (h) after collection. Samples should be analyzed as soon as possible after collection.
Positive test results do not exclude simultaneous infection with other pathogens.
Positive test results do not distinguish between SARS-CoV and SARS-CoV-2 viruses.
Negative test results are not intended to rule out other viral or bacterial infections unrelated to SARS.
Negative test results in patients with symptoms lasting more than seven days should be considered probable. This category of patients requires additional molecular analysis.
If isolation of specific viruses and strains of COVID-19 pathogens is required, additional testing should be performed, taking into account consultation with the state or local health department.
General characteristics
PERFORMANCE CHARACTERISTICS
Detection limit (analytical sensitivity)
The detection limit of the Rapid Test for COVID-19 Virus Antigen (viral fluid (confirmed by a positive reaction to the PCR test, from Orient Gene)) was confirmed in 5 repetitions and is 22.5 TCID50/mL.
Sensitivity, specificity and overall convergence
A rapid test for the detection of COVID-19 virus antigen (nasopharyngeal swab sample) was compared with a commercial PCR test (manufactured by Orient Gene):
PCR
In general
positive
negative
Rapid test for COVID-19 virus antigen detection
positive
198
1
199
negative
2
249
251
In general
200
250
450
Convergence, %
≥ 99.0%
≥ 99.6%
99.3%
The overall agreement, according to the table above, is 99.3%; 95% CI (98.0% - 99.9%).
Number of days after onset of symptoms
Number of samples
PCR positive samples
Rapid test for COVID-19 virus antigen detection
95% CI
1
44
44
44 (100.0%)
90.4% - 100%
2
76
76
76 (100.0%)
94.2% - 100%
3
65
65
65 (100.0%)
93.3% - 100%
4
15
15
13 (100.0%)
60.9% - 97.5%
Total
200
200
198 (99.0%)
88.8% - 97.0%
The overall sensitivity for SARS-CoV-2 (COVID-19) virus antigen is 99.0%; 95% CI: (88.8% - 97.0%).
Number of samples
PCR
negative samples
Rapid test for COVID-19 virus antigen detection
250
250
249/250 = 99.6%
Total
Not applicable
99.6%
95% CI (98.5% - 99.1%)
The overall specificity, according to the table above, is 99.6%; 95% CI (98.5% - 99.1%).
Cross-reactivity
The rapid test for the detection of COVID-19 virus antigen was tested on the following pathogen samples:
Candida albicans
1×108 CFU/ml (org/ml)
Influenza A H3N2
1×105 TCID50/ml (ml)
Staphylococcus epidermidis
1×108 CFU/ml (org/ml)
Influenza B
3.16×106 TCID50/ml (ml)
Staphylococcus aureus subspaureus
1×108 CFU/ml (org/ml)
Human rhinovirus 2
2.81×104 TCID50/ml (ml)
Corynebacterium
1×108 CFU/ml (org/ml)
Human rhinovirus 14
1.58×106 TCID50/ml (ml)
Streptococcus pneumoniae
1×108 CFU/ml (org/ml)
Human rhinovirus 16
8.89×106 TCID50/ml (ml)
Escherichia coli
1×108 CFU/ml (org/ml)
Measles
1.58×104 TCID50/ml (ml)
Streptococcus pyogenes
1×108 CFU/ml (org/ml)
Mumps
1.58×104 TCID50/ml (ml)
Moraxella catarrhalis
1×108 CFU/ml (org/ml)
Parainfluenza virus 2
1.58×107 TCID50/ml (ml)
Streptococcus salivarius
1×108 CFU/ml (org/ml)
Parainfluenza virus 3
1.58×108 TCID50/ml (ml)
Neisseria lactamica
1×108 CFU/ml (org/ml)
Respiratory syncytial virus
8.89×104 TCID50/ml (ml)
Streptococcus sp group F
1×108 CFU/ml (org/ml)
Human coronavirus 229E
1×106 TCID50/ml (ml)
Nesseria subflava
1×108 CFU/ml (org/ml)
Middle East Respiratory Syndrome (MERS-CoV)
1.5×106 TCID50/ml (ml)
Pseudomonas aeruginosa
1×108 CFU/ml (org/ml)
Human coronavirus OC43
2.45×106 LD50/ml (ml)
Arcanobacterium
1×108 CFU/ml (org/ml)
Coronavirus NL63
1×105.07 Units/ml (U/ml)
Influenza A H1N1
3.16×105 TCID50/ml (ml)
Human coronavirus 2013 SARS
1.5×106 TCID50/ml (ml)
The results revealed no cross-reactivity.
Interfering substances
The sensitivity and specificity of the rapid test for the detection of COVID-19 virus antigen (nasopharyngeal swab sample) are not affected by the substances listed below:
