Henan Lantian Medical Supplies Co.,Ltd. |
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The kit is for qualitative testing of nCoV Ag 2019 strains taken
from human nose wipe samples.
The 2019 nCOV is the new nCOV. Viral pneumonia can be caused and
the main clinical symptoms are fever, lethargy and dry cough. Many
patients have symptoms such as stuffy nose, runny nose, sore
throat, and diarrhea. Severe patients usually develop dyspnea and /
or hypoxemia after 1 week, and severe patients rapidly develop
acute respiratory distress syndrome, infectious shock, difficulty
in correcting metabolic acidosis, coagulation dysfunction, etc.
Proceed.
This product was qualitatively tested by transverse flow
immunoassay on a pseudo-nasal wipe sample of 2019 nCoV Ag. During
the acute phase of infection, antigen is usually detected in nasal
swap samples. A positive result indicates the presence of a viral
antigen, but a clinical correlation between the patient's medical
history and other diagnostic information is also needed to identify
the infection status. Positive results do not rule out bacterial or
mixed infections with other viruses.
This kit can be used by the general public at home in
non-laboratory environments (human homes and non-traditional places
such as offices, sporting events, airports, schools). The test
results of this kit are for clinical reference only. It is
advisable to perform a full analysis of the condition based on the
patient's clinical symptoms and other laboratory tests.
This kit is an immunoassay kit based on the principle of two-antibody concentric technology. The 2019 ncov monoclonal antibody bearing this marker was sprayed onto the binding sheet as an indicator marker. During the course of the test, the 2019 ncov Ag in the sample is bound to the labeled 2019 ncov monoclonal antibody to form the ag-ab complex. The complex was elevated by the capillary effect and was separately packaged on the test line until the sandwich complex was formed by the 2019 ncov monoclonal antibody. A red stripe appeared in the T zone of ncov Ag in 2019. This is the explanation window in the sample. Otherwise, this is a negative result. The control line (c) is used for program control. If the test program runs correctly, it should always be visible.
The kit consists of a test card, sample buffer and a wipe.
Test card: Consists of aluminum foil packaging, desiccant, test
sheet, plastic card. Of these, the test paper consists of a
water-absorbent paper, a cellulose nitrate film, a test sample pad,
an adhesive pad and a rubber plate. The nitrocellulose membrane T
line (test line) is packaged with 2019 nCOV Ab, C line (QC line),
coated with goat anti-mouse multiclonal antibody, and the binding
pad is labeled 2019 nCOV Ab.
Sample buffer: Phosphate, sodium nitride, etc.
Stay at 2 ℃ ~ 30 ℃, tentatively valid for 18 months.
The unpacking aluminum foil package is valid for one hour.
Production batch number: See the label for details.
Validity period: See the label for details.
(1)How to remove the nostril: Insert the sample swap into the nostril and insert the tip into the nostril edge 2.5 cm. Turn the brush 5 times along the mucous membrane of the nose and repeat the same for the other nose with the same brush.(see Figure 1)
Figure 1 Collection method for nasal swab
(2) Sample processing: Collected samples should be treated with the sample buffer provided by the kit as soon as possible (if not immediately, stored in a dry, sterile, sealed container), stored within 2 hours, temperature 24 hours ° C. Maintain -70 ° C without exceeding ~ 8 ° C (but avoid repeated freezing and thawing)
Please read the instructions carefully before the test. Bring all
reagents to room temperature before testing. The test should be
conducted at room temperature.
1 Sample processing (see Fig. 2)
1. Insert the sample swap into the sample buffer and rotate it
approximately 10 times near the inner wall to allow the sample to
dissolve as much as possible in the solution.
2. Squeeze the tip of the wipe along the inner wall of the tube,
pour as much liquid as possible into the tube, take out the wipe
and put it in the house.
3. Cover with water drops.
Figure 2 Sample
processing
Figure 3 Detection procedure
2. Test procedure (see Figure 3)
1. took out the exam card.
The 2. adds 2 drops (about 80 μ50) extracts the processed sample into the loading hole of the test card and then activates the timer.
3. read the results after 15 minutes at room temperature. Invalid results after 20 minutes.
Test card description (Figure 4):
Invalid ① Result: Quality control line (C line) The response line
is invalid and should be rediscovered.
② Negative result: Quality control line (C) is a red ribbon.
③ Positive result: 2 red bands, test (T) and quality control (C).
Figure 4 Interpretation of test results
1. This product is used for qualitative tests and is used only for
in-vitro assisted diagnosis.
2. This product is suitable for nose wipe samples. The results of
other types of samples may be inaccurate or invalid.
3. An appropriate amount of sample must be added and tested. If the
sample size is too large or too small, the results may be
inaccurate.
4. The test results of this reagent are for clinical reference only
and cannot be the sole basis for clinical diagnosis and treatment.
A final diagnosis can be made after a comprehensive evaluation of
all clinical and laboratory results.
1. Detection limit: When using inactivated novel coronavirus
culture, the minimum detection limit of the kit is 6 × 102 TCID 50
/ mL.
2. Tested using the company reference product, the results should
meet the company reference product requirements.
2.1 Positive quality control products Pass rate: P1-P5 Positive All
quality control products are positive.
2.2 Negative control pass rate: All negative controls N1-N10 are
negative.
2.3 Test limit: Minimum test limit Reference product L1-L3, L1
Negative and positive L2 and L3.
2.4 Reproductivity: J1 and J2, 10 times each time.
3. Cross-reactivity: Add the following concentrations of
microorganisms and viruses to the sample at the specified
concentrations to assess potential interference with the 2019 nCoV
Ag test program. As a result, it was found that there was no
cross-reactivity and no interference by 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. Interference: The 2019 nCoV Ag test program will add the following concentrations to the sample at the specified concentration to assess its potential interference. As a result, none of the drugs interfered with the test results of the reagents.
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: No 106 TCID 50 / ml × 2019 nCoV inactivated
cultures were observed in the high concentration range of 1.0.
6. Clinical study: Evaluate nasal wipe samples using reverse
transcription polymerase chain reaction detection reagent as a
comparative agent. Select 120 positive samples and 120 negative
samples (rt-pcr test) and detect with xiu reagent. The results can
be 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 used only for in vitro diagnosis.
2. This product is a disposable product and cannot be collected.
3. Read the instructions carefully before operating and perform the
experimental operation strictly according to the reagent
instructions.
4. Avoid experiments in harsh environments containing high
concentrations of corrosive gas, dust, sodium hypochlorite, alkalis
and acetaldehyde. The laboratory must be disinfected after the
experiment is over.
5. All samples and reagents used by the company are considered
potential contagious substances and are treated according to local
regulations.
6. Reagents should be used within the shelf life specified on the
package. Remove the test card from the aluminum foil bag and use it
as soon as possible 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 Web:www.zosbio.com | |
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