Where To Get Home Diagnostic COVID 19 Test Kit High Accurate
Coronavirus Antigen Test By Throat Swab Or Nasal Swab
COVID-19 Antigen Rapid Test Cassette
For the qualitative detection of SARS-CoV-2 antigen in human throat
swab or nasal swab
Main Features
☀ High Sensitivity, Some Products can reach 100%
☀ High Specificity, Some Products can reach 100%
☀ Reliable: High Accurate, Early Detection of The Presence Of Virus
☀ Simple: No complicated Instrument Required
☀ Convenient: Room Temperature Storage, patented Built-In Control
line for easy operation with high accuracy
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Intended Use
COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative
detection of specific antigens to SARS-CoV-2 present in human
throat or nasal cavity. It cannot be used as the basis for the
diagnosis and exclusion of COVID-19.
This reagent is used to detect cases with suspected symptoms of
COVID-19 within 7 days. If suspected symptoms are more than 7 days,
it is recommended to test with COVID-19 antibodies or nucleic acid
reagents.
Principle
This kit uses double antibody sandwich immunoassay to detect
specific antigens to SARS-CoV-2 in human throat or nasal cavity.
The membrane was precoated with SARS-CoV-2 specific antibody on the
test zone and goat anti mouse IgG antibody on the control zone.
During the test, the specimen is allowed to react with SARS-CoV-2
specific antibody-colloidal gold particles conjugate, which was
predried on the test. The conjugate binds to the SARS-CoV-2 forming
an Antibody~Antigen complex.
Materials Required But Not Provided
☀ Timer or stopwatch
☀ Biohazard disposal container
☀ Disposable gloves
☀ Disposable sampling swab
Sample Collection
☀ Throat Swab Sample
Take a disposable sampling swab out, insert it into the throat of
the patient. Use the swab to gently wipe the pharyngeal tonsils on
both sides of the patient for at least 3 times, and then wipe them
on the posterior pharyngeal wall for at least 3times. Withdraw the
swab from the throat.
☀ Nasal Swab Sample
Take a disposable sampling swab out, insert it into the nostril of
the patient. Carefully insert the swab into the nostril. Gently
rotating, pushing the swab until meet resistance at the level of
the turbinates (less than one inch into the nostril). Rotate the
swab several times against the nasal wall then remove it from the
nostril.
Interpretation of Results
☀ Positive: One color line in the control zone (C) and one color
line in the test zone (T). This indicates that the sample contains
SARS-CoV-2 antigen.
☀ Negative: Only one color line in the control zone (C). This
indicates that no SARS-CoV-2 antigen has been detected.
☀ Invalid: If no color line appears in the control zone (C), the
test is invalid. Discard the test cassette and perform with new
cassette.
Performance Characteristics
1. Negative reference sample coincidence rate: 10 negative
enterprise reference samples were tested and the
results were all negative.
2. Positive reference sample coincidence rate: 5 antigen positive
enterprise reference samples were tested and the
results were all positive.
3. Minimum detectability:
3.1 3 limited detection of enterprise reference samples were used
for testing, repeated 3 times, L1 should be negative, L2 and L3
should be positive.
3.2 The minimum detectability of this product for the SARS-CoV-2
virus strain is no more than 1.25×103.2TCID50/ml.
4. Intra-lot repeatability: Parallel determination of enterprise
repeatable reference samples, each repeated 10 times,
R1 should be negative, R2 and R3 should be positive.
5. Inter-lot repeatability: Parallel determination of enterprise
repeatable reference samples with 3 batches of reagents, each batch
repeated 10 times. With 3 batches of reagents, R1 should be
negative, R2 and R3 should be positive.
6. Interfering substances: α - interferon, zanamivir, ribavirin,
ritonavir, pramivir, lopinavir, abidol, levofloxacin, azithromycin,
ceftriaxone, meropenem, tobramycin have no effect on the test
results of this product.
7. Cross reaction: There was no cross-reaction with potential
cross-reactive substances.
| Virus/Bacteria/Parasite | Strain | Concentration | Results |
| Coronavirus | OC43 | 1.0×105 TCID50/ml | NEG |
| NL63 | 1.0×104 TCID50/ml | NEG |
| Adenovirus | Type 3 | 1.5×106 TCID50/ml | NEG |
| Type 7 | 1.5×106 TCID50/ml | NEG |
| Type 55 | 4.0×105 TCID50/ml | NEG |
| Influenza A | A/14160(H1N1) | 3.0×105 TCID50/ml | NEG |
| A/44045 (H3N2) | 1.0×105 TCID50/ml | NEG |
| Influenza B | B/1704 | 2.5×105 TCID50/ml | NEG |
| B/179 | 4.0×105 TCID50/ml | NEG |
| Respiratory syncytial virus | Type A | 3.0×105 TCID50/ml | NEG |
| Mycoplasma pneumoniae | Mutant 22 | 5.0×104 cells/ml | NEG |
| Streptococcus pneumonia | 178 [Poland 23F-16] | 5.0×104 cells/ml | NEG |
| Legionella pneumophila | Bloomington-2 | 5.0×104 cells/ml | NEG |
| Mycobacterium tuberculosis | HN878 | 5.0×104 cells/ml | NEG |
| RhinovirusA16 | N/A | 1.0×105 TCID50/ml | NEG |
Warning
For Medical Professional and In Vitro Diagnostic use ONLY
Read the package insert completely before use. It is very important
that the correct procedure is followed. Fail to add the patient
sample may lead to a false result.
