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 was used in 2019 for a qualitative test of new corona
virus antigens. Collected from human saliva/sputum samples.
The new corona virus is a new corona virus that may cause viral
pneumonia. Clinical symptoms are fever, fatigue, dry cough, a small
number of patients with nosebleed, runny nose, sore throat,
diarrhea and other symptoms. Severe cases usually develop hypoxia
after dyspnea and/or only one week, while severe cases develop
rapidly with acute respiratory distress syndrome, septic shock,
metabolic disorders, and coagulation disorders.
Legalization of the new CORONA virus antigen, detected from
saliva/saliva samples of suspected patients using Sidfreume Noazel.
Antidepressants are usually detected in saliva/saliva samples
during the acute phase of infection. A positive result indicates
the presence of viral antigens, but clinical correlations between
the patient's history and other diagnostic information are also
necessary to determine the status of infection. A positive result
does not rule out bacterial infection or other virus-related
infections. The pathogen detected may not be the correct cause of
infection. Negative disease results cannot be ruled out. Please do
not use COVID-19 as a 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 experience and medical history, consistent with the
new coronavirus, and nucleic acid analysis should be conducted
according to confirmed clinical signs and symptoms.
The kit consists of test card, sample buffer storage and swab.
The test card: Paper consisting of aluminum foil bags, desiccant,
test paper and plastic cards includes absorbent paper, nitro fiber
film, sample pad, rubber pad, 2019 Nitro cotton film mixed T-line
(test line) package-NCOVAB made of rubber sheet, and C-line (QC
line) package-for goat anti-rat polyclonal antibody. Binding pad
with 2019-NCOVAB label.
Sample buffer: phosphoric acid, nitrile azo, etc.
The temperature is maintained at 2-30 ℃ for 18 months.
The aluminum foil package will remain valid for 1 hour after
opening.
Production Lot Number: Refer to the label for details.
Expiry date: Refer to the label.
(1) Saliva sample collection: Do not eat or drink chewing gum or
cigarette products within 30 minutes after saliva sample
collection. Place your tongue on the lid of your mouth to collect
saliva roots. I put the disposable tampons under it. Soak your
tongue for at least 10 seconds, completely soaking it in saliva,
and rotate it more than 5 times (see table 1).
Note: Saliva sample is not collected correctly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Sputum collection: after rinsing with water, sputum is
continuously coughed. Put the sputum into the test bag and wipe the
sample with a disposable disinfection cotton swab (refer to Figure
2).
(3) Sample processing: The collected samples are processed with the
sample buffer memory contained in the toolbox (the samples not
immediately processed are kept in a dry and germicidal sealed
container). 2 ~ 8℃ ~ 24 hours above 70 ℃ (but please avoid repeated
freezing and thawing).
Please read the instructions carefully before the exam. All
reagents are returned to room temperature, and tests must be
performed at room temperature.
Processing example (see Figure 3).
(1) Insert the sample exchanger into the sample buffer memory,
rotate it around the inner wall for about 10 times, and dissolve
the sample into the solution as much as possible.
(2) Hold the front end of the casing along the inner wall, pour the
liquid into the pipe, remove the casing, and discard the casing.
(3) Cover with water droplets.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test process (see Figure 4).
(1) Remove the test card.
(2) Add 2 drops (about 80L) of the processed sample extract into
the sample hole of the test card to start the timer.
(3) After reading the card at room temperature for 15 minutes, the
result is invalid after 20 minutes.
Figure 5 Interpretation of test results
1. This product is a qualitative test, only for the purpose of
assisting invitro diagnosis.
2. This product is suitable for saliva and sputum samples. Results
of other sample types may be inaccurate or invalid.
3. In the absence of sputum samples, patients should be examined
with a nasopharyngeal swan.
4. Confirm that the appropriate number of additional test samples
has been added. With too many or too many samples, the results may
be incorrect.
5. The test results of the reagent are only for clinical reference,
and should not be used as the only basis for clinical diagnosis and
treatment. A final diagnosis of the disease must be made after a
comprehensive evaluation of all clinical and examination results.
1. Detection limits: Inactive SARS-COV-2 virus cultures were used
in this study. The minimum detection limit is 612tcid50/ml.
2. Use the company's standard materials for testing, and the test
results must meet the requirements of the company's standard
materials.
2.1 Qualification rate of positive control: the enterprise actively
controls P1-P5.
2.2 Pass rate of negative control: The company's N1-N10 negative
control test is negative.
2.3 Test limit: please refer to L1-L3. L1 is negative, L2 and L3
are positive.
2.4 Reproducibility: BOTH J1 and J2 were 10 times positive.
3. Cross-reactivity: The following microorganisms and viruses are
injected into the sample at specified concentrations to evaluate
potential interference with the 2019 new corona virus antigen
detection program.
4. Interference: The 2019-NCOV Ag test procedure evaluates
potential interference and adds the following agents at specified
concentrations. The results showed that the various drugs did not
interfere with the test results of the reagent.
5. Hook effect: In the high concentration range of 1.0106
TCID50/mL, no hook effect was observed in 2019-NCOV inactive
culture.
6. Clinical study: RT-PLR sputum reagent was used as contrast agent
to detect saliva and sputum samples respectively. For each sample
size (RT-PLR test), 120 positive and negative samples were selected
and a second test was performed using XIUS reagent. The results are
as follows:
1. This product is used for INVitro diagnosis.
This product is disposable and can't be reused.
3. Please strictly follow the instructions of reagents and read the
instructions carefully before the experiment.
4. Do not perform the test under severe environmental conditions
(including 84 disinfectant, dust, sodium hypochlorite, acid and
alkali, acetaldehyde and other corrosive gases with high
concentration). Laboratory disinfection needs to be carried out
after the experiment.
| 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
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
