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Brand Name : | ZOSBIO |
Model Number : | 2019-NCoV Ag Rapid Test |
Certification : | CE BfArm |
Price : | To be negotiated |
Supply Ability : | 10000 Kit/Kit per Day |
Delivery Time : | To be negotiated |
The kit is used for qualitative detection of 2019-n coronavirus
antibody collected from human nasal swab samples.
As a new product, 2019-ncov is β- A kind of cov. It can cause viral
pneumonia. The main clinical manifestations are fever, fatigue and
dry cough. A few patients have nasal congestion, runny nose, sore
throat, diarrhea and other symptoms. Severe patients often develop
dyspnea and / or hypoxemia after 1 week. Severe patients rapidly
progress to acute respiratory distress syndrome, septic shock,
refractory metabolic acidosis and cotting dysfunction.
This product uses lateral flow immunoassay to detect 2019-n
coronavirus antibody in nasal swabs of suspected patients. In the
acute phase of infection, antigens are usually detected in nasal
swab samples. Positive results indicate the presence of viral
antigens, but the clinical correlation between patient history and
other diagnostic information is also necessary to determine the
status of infection. The positive results do not exclude bacterial
infection or co infection with other viruses.
The kit is intended for non professionals to use in non laboratory
environments at home (such as individual homes or some
non-traditional places, such as offices, sports events, airports,
schools, etc.). The test results of this kit are only for clinical
reference. It is recommended to analyze patients in combination
with clinical findings and other laboratory tests.
The kit is an immunoassay kit based on the principle of double antibody sandwich technology. As an indicator, the labeled 19ncov monoclonal antibody was sprayed on the binding pad. During the detection, the 2019-ncov antibody in the sample binds to the labeled 2019-ncov monoclonal antibody to form an Ag antibody complex. The complex migrates upward on the membrane through capillary effect until it is captured by another 2019-n coronavirus monoclonal antibody pre coated on the test line to form a sandwich complex. If there is 2019-ncovag in the sample, a red strip will appear in the T area of the description window. Otherwise, it will be a negative result. The control line (c) is used for program control. If the test procedure is performed correctly, it should always be displayed.
The kit consists of test card, sample buffer and swab.
Test card: it is composed of aluminum foil bag, desiccant, test
strip and plastic card. The test paper is composed of absorbent
paper, nitrocellulose film, sample pad, rubber pad and rubber
sheet. Nitrocellulose membrane t line (detection line) is coated
with 2019ncov antibody, C line (quality control line) is coated
with Sheep anti mouse polyclonal antibody, and the binding pad
contains labeled 2019ncov antibody.
Sample buffer: phosphate, sodium azide, etc.
Stored at 2 ℃ ~ 30 ℃, the validity period is tentatively 18 months.
The validity period of aluminum foil bag is 1 hour.
Batch number: see the label for details.
Validity period: see the label for details.
(1) Nasal swab collection method: insert the sampling swab into the nostril, and the tip of the swab should be inserted 2.5cm away from the edge of the nostril. Roll the swab along the nostril mucosa five times, and then repeat the process with the same swab on the other nostril. (see figure I)
Figure 1 Collection method for nasal swab
(2) Sample treatment: the collected samples shall be treated with the sample buffer provided by the kit as soon as possible (if not treated immediately, the samples shall be stored in dry, sterile and sealed containers), stored at 2 ℃ ~ 8 ℃ for no more than 24 hours, and stored at - 70 ℃ for a long time (but avoid repeated freezing and thawing).
Please read the instructions carefully before taking the exam.
Before testing, please put all reagents back to room temperature
and test at room temperature.
1. Sample processing (see Figure 2)
1. Insert the sample swab into the sample buffer and rotate it
around the inner wall for about 10 times to make the sample
dissolve in the solution as much as possible.
2. Squeeze the tip of the cotton swab along the inner side of the
pipe, let as much liquid as possible enter the pipe, take out and
discard the cotton swab.
3. Cover the dryer.
Figure 2 Sample processing
Figure 3 Detection procedure
2. Test procedure (see Figure 3)
1. Take out the test card.
2. Add 2 drops (approx. 80 μ 50) extract the processed sample into
the loading hole of the test card, and then start the timer.
3. Read the results after 15 minutes at room temperature. Twenty
minutes later, the result is invalid
Test card reading (Figure 4):
① Invalid result: the quality control line (line C) has no reaction
line and is invalid. It shall be retested.
② Negative result: the quality control line (line C) is colored
with red strips.
③ Positive results: two red bands were stained with test line (t
line) and quality control line (C line).
Figure 4 Interpretation of test results
1. This product is used for qualitative detection and is only used
for in vitro auxiliary diagnosis.
2. This product is applicable to nasal swab samples. Other sample
types may have inaccurate or invalid results.
3. Be sure to add an appropriate number of samples for testing. Too
many or too few samples will lead to inaccurate results.
4. The test results of this reagent are only for clinical reference
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
a comprehensive evaluation of all clinical and laboratory results.
1. Detection limit: the inactivated sars-cov-2 virus culture was
used in this study, and the minimum detection limit of the kit was
6 × 102TCID50/mL.
2. The test results shall meet the requirements of our company's
reference products.
2.1 qualification rate of positive control samples: all p1-p5
positive control samples of the company are positive.
2.2 compliance rate of negative control substance: enterprises
n1-n10 are negative.
2.3 detection limit: L1 is negative, L2 and L3 are positive.
2.4 repeatability: the repeated reference materials J1 and J2 were
tested in the enterprise, and each test result was positive for 10
times.
3. Cross reaction: add the following concentrations of
microorganisms and viruses to the samples with the specified
concentration to evaluate their potential interference to the
2019-ncovag test project. The results showed that there was no
cross reaction and no interference of various microorganisms and
viruses.
SN | Microorganisms | Concentration | Cross reaction |
1 | Coronavirus (HKU1, OC43, NL63 and 229E) | 1.0×105TCID50/mL | No |
2 | H1N1 influenza (new type A H1N1 influenza virus (2009), seasonal H1N1 influenza virus), H3N2, H5N1, H7N9 | 1.0×105TCID50/mL | No |
3 | Influenza B (Yamagata strain, Victoria strain) | 2.5×105TCID50/mL | No |
4 | Respiratory syncytial virus | 2.8×105TCID50/mL | No |
5 | Group A, B, C of rhinovirus | 2.0×105TCID50/mL | No |
6 | Type 1, 2, 3, 4, 5, 7, 55 of adenovirus | 2.0×105TCID50/mL | No |
7 | Group A, B, C and D of enterovirus | 2.0×105TCID50/mL | No |
8 | EB virus | 2.0×105TCID50/mL | No |
9 | Measles virus | 2.0×105TCID50/mL | No |
10 | Human cytomegalovirus | 2.0×105TCID50/mL | No |
11 | Rotavirus | 2.0×105TCID50/mL | No |
12 | Norovirus | 2.0×105TCID50/mL | No |
13 | Mumps virus | 2.0×105TCID50/mL | No |
14 | Varicella-zoster virus | 2.0×105TCID50/mL | No |
15 | Mycoplasma pneumoniae | 1.0×106CFU/mL | No |
16 | Legionella pneumophila | 1.0×106CFU/mL | No |
17 | Haemophilus influenzae | 1.0×106CFU/mL | No |
18 | Streptococcus pyogenes (group A) | 1.0×106CFU/mL | No |
19 | Streptococcus pneumoniae | 1.0×106CFU/mL | No |
20 | Escherichia Coli | 1.0×106CFU/mL | No |
21 | Pseudomonas aeruginosa | 1.0×106CFU/mL | No |
22 | Neisseria meningitidis | 1.0×106CFU/mL | No |
23 | Candida albicans | 1.0×106CFU/mL | No |
24 | Staphylococcus aureus | 1.0×106CFU/mL | No |
4. Interfering substances: In 2019, the following concentrations of drugs will be added to the samples with specified concentrations to evaluate their potential interference to nCoVAg testing items. The results showed that all kinds of drugs did not interfere with the detection results of the reagent.
Interfering substances | Concentration | Interfering substances | Concentration |
Mucoprotein | 1mg/mL | Ribavirin | 0.4mg/mL |
Whole Blood | 1% | Fluticasone | 0.5mg/mL |
Oxymetazoline | 10mg/mL | Dexamethasone | 5 mg/mL |
Histamine hydrochloride | 10mg/mL | Triamcinolone acetonide | 5mg /mL |
Tobramycin | 1mg/mL | Levofloxacin | 0.2 mg/mL |
Oseltamivir | 1mg/mL | Azithromycin | 0.1 mg/mL |
Zanamivir | 1mg/mL | Ceftriaxone | 0.4 mg/mL |
Arbidol | 0.5mg/mL | Meropenem | 0.2 mg/mL |
5. Hook effect: after 2019 ncov inactivation culture, at 1.0 × No
hook effect was observed within the detection range of 106tcid50 /
ml high concentration.
6. Clinical study: RT-PCR reagent was used as a contrast agent to
evaluate nasal swab samples. A total of 120 positive samples and
120 negative samples (RT-PCR) were selected for intermediate
reagent detection. The results are summarized as follows:
Nasal swab | RT-PCR | Sum | ||
Positive | Negative | |||
![]() | Positive | 116 | 2 | 118 |
Negative | 4 | 118 | 122 | |
Sum | 120 | 120 | 240 | |
Sensitivity | 96.67%, (95%CI: 91.74%~98.70%) | |||
Specificity | 98.33%, (95%CI: 94.13%~99.54%) |
1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be reused.
3. Please read the operating instructions carefully before
operation and carry out the experimental operation in strict
accordance with the reagent operating instructions.
4. Avoid conducting experiments under harsh environmental
conditions (including 84 disinfectants, sodium hypochlorite,
acid-base, acetaldehyde and other high concentration corrosive
gases and dust). The laboratory shall be disinfected after the
experiment.
5. All samples and reagents used should be treated as potentially
infectious substances and handled in accordance with local
regulations.
6. The reagent shall be used within the validity period indicated
on the outer package. Use as soon as possible after taking it out
of the aluminum foil bag to prevent moisture.
![]() | Do not re-use | ![]() | Store at 2℃~30℃ |
![]() | Consult instructions for use | ![]() | In vitro diagnostic medical devic |
![]() | Batch code | ![]() | Use-by date |
![]() | Keep dry | ![]() | Keep away from sunlight |
![]() | Authorized representative in the European Community | ![]() | Manufacturer |
![]() | ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA Tel:+86-371-55016575 Email:zosbio@zosbio.com |
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