Active Member
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[China]
Address: Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
Contact name:chen
Henan Lantian Medical Supplies Co.,Ltd. |
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This kit is used for the qualitative test of 2019 nCoV Ag.
Collected from human saliva/sputum samples.
2019 nCOV is a new type of β-COV that can cause viral pneumonia.
The clinical manifestations are fever, fatigue, dry cough, and a
few patients have symptoms such as nasal congestion, runny nose,
sore throat, and diarrhea. Severe patients usually develop dyspnea
and/or hypoxemia after a week, and severe patients rapidly develop
acute respiratory distress syndrome, septic shock, metabolic
acidosis, and coagulopathy.
Use lateral flow immunoassay to legalize the detection of 2019 nCoV
Ag in saliva/sputum samples of suspicious patients. During the
acute phase of infection, antigens are usually detected in
saliva/sputum samples. A positive result indicates the presence of
viral antigens, but the clinical correlation between the patient’s
medical history and other diagnostic information is also necessary
to determine the infection status. A positive result does not
exclude bacterial infections or infections related to other
viruses. The detected pathogen may not be the exact cause of the
infection. Negative disease results cannot exclude 2019 nCoV
infection and should not be used as the basis for treatment or
patient management decisions, including infection control
decisions. If the result is negative, the final decision should be
made based on the patient's recent contact history, medical
history, and whether there are clinical signs and symptoms
consistent with 2019 nCoV (if necessary, it can be confirmed by
nucleic acid analysis).
The kit consists of a test card, sample buffer and swab.
Test card: It is composed of aluminum foil bag, desiccant, test
paper and plastic card. The paper consists of absorbent paper,
nitrocellulose membrane, sample pad, rubber pad and rubber sheet.
The nitrocellulose membrane T line (test line) is packaged as
2019-NCOV Ab, the c line (QC line) is packaged as goat anti-mouse
polyclonal antibody, and the binding pad contains the label
2019-NCOV Ab.
Sample buffer: phosphate, sodium azide, etc.
The temperature is maintained at 2 to 30 degrees Celsius, and the
temporary validity period is 18 months.
The aluminum foil bag is effective within one hour after opening.
Production batch number: see label for details.
Validity period: see label for details.
(1) Saliva sample collection: Do not eat or drink within 30 minutes
after saliva sample collection, including chewing gum or using
tobacco products. Place the tip of the tongue against the upper jaw
and collect the saliva roots. Put the disposable sterile cotton
swab under the tongue for at least 10 seconds with the tongue, soak
it completely in the saliva, and rotate it more than 5 times. (See
Table 1)
Note: If the saliva sample is not collected properly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum specimen collection: After washing with water,
expectorate the sputum, put it into the specimen bag, and wipe the
specimen with a disposable sterile cotton swab. (See Figure 2)
(3) Sample processing: The collected samples should be processed
using the sample buffer provided by this kit (not processed
immediately, the samples should be stored in a dry, sterilized,
sealed container) for inspection. 2℃~8℃ shall not exceed 24 hours
and -70℃ for a longer time (but avoid repeated freezing and
thawing).
Please read the instructions carefully before testing. Return all
reagents to room temperature, and the test should be carried out at
room temperature.
Sample processing (see Figure 3).
(1) Insert the sample swab into the sample buffer and rotate it
about 10 times close to the inner wall to make the sample dissolve
in the solution as much as possible.
(2) Squeeze the tip of the swab along the inner wall to make the
liquid flow into the tube, remove and discard the swab.
(3) Cover with water droplets.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test procedure (see Figure 4).
(1) Take out the test card.
(2) Add 2 drops (about 80L) of the processed sample extract to the
sample hole of the test card and start the timer.
(3) Put the card at room temperature for 15 minutes to read the
result, and the result will be invalid after 20 minutes.
Explanation of the test card (see Figure 5):
1. Result: The quality control line (line C) should be re-checked.
2. Negative results: quality control line (line C), red ribbon,
coloring.
3. Positive result: There are two red strip colors on the test line
(line t) and the quality control line (line C).
Figure 5 Interpretation of test results
1. This product is a qualitative test and is only used to assist in
vitro diagnosis.
2. This product is suitable for saliva and sputum samples, other
sample types may have inaccurate or invalid results.
3. If the patient does not have a sputum sample, a nasopharyngeal
swab should be used for testing.
4. Make sure to add the right amount of sample for testing. Too
many or too few samples may lead to inaccurate results.
5. The test results of this reagent are for clinical reference
only, and should not be used as the sole basis for clinical
diagnosis and treatment. After a comprehensive evaluation of all
clinical and laboratory results, the final diagnosis of the disease
should be made.
1. Detection limit: This study uses inactivated sars-cov-2 virus
culture, and the minimum detection limit of the kit is
6102tcid50/ml.
2. Use corporate standard materials for testing, and the test
results should meet the requirements of corporate standard
materials.
2.1 Pass rate of positive control: The enterprise is positively
controlling p1-p5.
2.2 Negative control qualification rate: the company's n1-n10
negative control test is negative.
2.3 Detection limit: Refer to L1-L3, L1 is negative, L2 and L3 are
positive.
2.4 Reproducibility: J1 and J2 were positive 10 times.
3. Cross-reaction: The following microorganisms and viruses are
added to the sample at the specified concentration to evaluate
their potential interference with the 2019 ncov Ag detection
program. Virus
| SN | Microorganisms | Concentration | Cross reaction |
| 1 | Coronavirus (HKU1, OC43, NL63 and 229E) | 1.0×105TCID50/mL | No |
| 2 | Influenza A H1N1 (novel influenza A H1N1 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: Assess potential interference with the 2019-nCoV Ag testing procedure and add the following medications at the indicated concentration. The results showed that all kinds of drugs did not interfere with the test results of 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 | 5 mg/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: In the 2019-NCOV inactivated culture, no hook
effect was observed in the high concentration range of 1.0106
TCID50/mL.
6. Clinical research: RT-PCR detection reagents are used as
contrast reagents to detect saliva and sputum samples respectively.
For each sample size (RT-PCR test), select 120 positive and 120
negative samples, and use XIUS reagent for the second test. The
results are summarized as follows:
1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Strictly follow the instructions of the reagents, and read the
instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including
high-concentration corrosive gases, such as 84 disinfectant, dust,
sodium hypochlorite, acid-base or acetaldehyde). Laboratory
disinfection should be carried out after the experiment.
5. The samples and reagents used should be considered as
potentially infectious and handled in accordance with local laws
and regulations.
6. The reagent should be used within the validity period indicated
on the outer packaging. The test card should be used as soon as
possible after being taken 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 device |
| 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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