Henan Lantian Medical Supplies Co.,Ltd. |
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The kit is used for the qualitative detection of ncovag. Exchange
specimens from nose collection
As a new weapon, 2019 ncov is a new weapon that may cause β - Viral
pneumonia, the main clinical symptoms are fever, fatigue and dry
cough. Many patients have a stuffy nose, runny nose, sore throat,
diarrhea or other symptoms. Important patients usually develop
dyspnea or hypoxemia after one week. Severe cases quickly developed
into acute respiratory distress syndrome, septic shock, refractory
metabolic acidosis and coagulation dysfunction.
The 2019 ncovag of suspected patients was detected by lateral
immunoassay. In the nasal examination, the antigen was detected.
Positive results show the presence of viral antigens, but the
clinical correlation between the patient's medical records and
other diagnostic information is also necessary to determine the
status of infection. The positive result is that bacterial
infection or simultaneous infection with other viruses cannot be
ruled out.
Remen uses the kit in non residential environments (personal homes,
offices, physical activities, airports, schools, etc.). The test
results of this kit can only be used for clinical reference.
Comprehensive analysis of clinical symptoms and other examinations.
This kit is based on the principle of double antibody sandwich technology. The ncov monoclonal antibody in 2019 is labeled and labeled on the binding pad. The test sequence is: 2019 ncovag ag19 cov monoclonal antibodies and combinations in the marked materials, 2019 ncov monoclonal antibodies in Ag AB complex are found, the body moves upward through capillarity, and the sandwich composite is formed. If there is a 2019 ncovag in the sample, a red band will appear in the T area of the description window. In addition, the results are negative. The control line (c) is used for program control. When the test program runs normally, it needs to be displayed all the time.
The kit consists of test card, sample package 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, test pad, adhesive pad and rubber pad.
In 2019nvvab (test line), t line covered with nitrocellulose film,
goat mouse cycle line AB (quality management line) and C in
2019nvvab. put sth. under sth. to raise it or make it level
Sample buffer: phosphoric acid, sodium nitride, etc.
Keep it at 2 ℃ ~ 30 ℃, and the validity period is tentatively 18
months.
The aluminum foil package can be used for 1 hour.
Production batch No.: please refer to the detailed label.
Please refer to talabel for details.
(1) Collect the tip of the nose: insert the sample swab into the nasal cavity, 2.5cm from the top of the nasal cavity. The cotton swab rotates 5 times along the medial nasal mucosa, and then repeat the process with the same cotton swab (see Figure 1).
Figure 1 Collection method for nasal swab
(2) Sample treatment: recycled samples must be treated with the sample buffer attached to this box as soon as possible (do not deal with it immediately. Store it in dry, sterilized and sealed containers) - 70 within 2 hours (but avoid repeated freezing and thawing).
Please read the instructions carefully before testing. All reagents
were tested at room temperature. Test at room temperature.
(1) Treatment process of test materials (see Figure 2)
Insert the sample exchange solution into the sample buffer, rotate
the sample about 10 times to the inner wall, and make it dissolve
into the solution as much as possible.
1. Inject liquid into the pipe along the front end of the inner
wall of the pipe and take out the waste.
2. Cover with a hair dryer..
Figure 2 Sample
processing
Figure 3 Detection procedure
(2) Test sequence (see Figure 3)
1. Take out the test card.
2. Add 2 drops μ 50), put the test material into the test card and
start the timer.
After 15 minutes, read the results at room temperature. After 5
minutes, the result is invalid.
Description of test card (Figure 4)
① Invalid result: the quality management line (line C) is invalid
and there is no response line, so it needs to be retested.
② Negative line result: the quality management line (line C) is a
red ribbon.
③ The positive result is all colors of two red bands, test line (T)
and quality management line (c).
Figure 4 Interpretation of test results
1. This product is used for qualitative test and only for invitro
diagnosis.
2. This product is suitable for nose samples. The results of other
sample types may be incorrect or invalid.
3. Properly add samples for testing. Too large or too small sample
size may lead to inaccurate results.
4. It should not be the only basis for clinical trials and
treatment. The final diagnosis can only be made after a
comprehensive evaluation of all clinical and experimental results.
1. detection limit: inactivated SARS - minimum detection limit 6 ×
102ttid 50 / ml cov-2 virus
2. The test using the enterprise reference product and its results
must meet the requirements of the enterprise reference product.
2.1 access rate of active management products: the P1 ~ P5 of
enterprises' active management products are reliable.
2.2 product time: the enterprise's negative control products N1 ~
N10 are negative.
2.3 detection limit: the minimum detection limit is detected by
referring to products l 1-L 3. L 1 is negative and L2 and L3 are
positive.
2.4 repeatability: the reference materials J1 and J2 are reused for
10 times by the tested company.
(3) Cross reactivity: in order to evaluate the potential
interference with the 2019 NCO vag test project, the following
microorganisms and viruses were added to the samples at the
specified concentration: This indicates that there is no cross
reactivity and interference from 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 the 2019 NCO vag trial, in order to evaluate the potential interference, it is planned to add the following concentrations of drugs to the sample. The results showed that all agents did not interfere with the test 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: within the high concentration range of 1.0. × 106
tcid 50 / ml, 19 ncov of inert culture was not found.
6. In clinical trials, RT-PCR test reagent was used to evaluate 120
positive and 120 negative (RT-PCR test), and Zhongxiu reagent was
used. The results are 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 invitro diagnosis.
This product is disposable and cannot be reused.
3. Please read the instructions carefully before operation and
operate in strict accordance with the reagent instructions.
4. Disinfect in the laboratory to avoid bad environmental
conditions, such as 84 disinfectant, sodium hypochlorite, acid-base
or acetaldehyde, other high concentration corrosive gases and dust.
5. All samples and reagents used will be considered as substances
that may be infected and treated in accordance with local laws.
6. Please use the reagent within the validity period indicated on
the packing box. Please use the test card as soon as possible after
taking it out of the aluminum foil bag.
![]() | 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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