Sample Requirements
(1) Saliva sample collection: Do not eat or drink water, including
chewing gum or using tobacco products within 30 minutes before
saliva sample collection. Hold the tip of the tongue against the
maxilla and collect the root of saliva. Tongue Place sterile
disposable cotton swabs under the root of tongue for at least 10
seconds, immerse them completely in saliva and rotate them more
than 5 times. (see figure 1)
Note: If saliva samples are not collected properly.
Figure 1 Methodsfor saliva sample collection
Figure 2 Methods for sputum sample collection
(2) Collection of sputum specimen: After rinsing with clear water,
cough up sputum and put it into the specimen bag, and wipe the
specimen with a disposable sterile cotton swab. (see figure 2)
(3) Sample treatment: The collected samples should be treated with
the sample buffer provided by this kit as soon as possible (they
should not be treated immediately, and the samples should be kept
in dry, sterilized and sealed containers) and kept for inspection.
2℃ ~ 8℃ shall not exceed 24h, and -70℃ shall not exceed for a long
time (but repeated freezing and thawing shall be avoided).
Test Method
Please read the instructions carefully before testing. Please
return all reagents to room temperature, and the test should be
carried out at room temperature.
1. Sample treatment (see Figure 3).
(1) Insert the sample swab into the sample buffer, and rotate it
close to the inner wall for about 10 times, so that the sample can
be dissolved 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, and take out and discard the swab.
(3) Cover with drops.
Figure 3 Sample processing
Figure 4 Test procedure
2. Test procedures (see Figure 4).
(1) take out the test card.
(2) Add 2 drops (about 80L) of the treated sample extract into the
sample hole of the test card, and then start the timer.
(3) Put the card at room temperature for 15 minutes to read the
result, and the result is invalid after 20 minutes.
Interpretation of Test Results
Interpretation of test card (see Figure 5):
1. result: the quality control line (line c) should be
re-inspected.
2. Negative results: quality control line (C line), red ribbon and
coloring.
3. Positive results: Two red bands of detection line (T line) and
quality control line (C line) were colored.
Figure 5 Interpretation of test results
Limitation of Test Method
1. This product is a qualitative test, which is only used to assist
in in vitro diagnosis.
2. This product is suitable for saliva and sputum samples, and
other sample types may have inaccurate or invalid results.
3. If there is no sputum specimen in patients, nasopharyngeal swab
specimens should be used for testing.
4. Ensure to add appropriate amount of samples for testing. Too
much or too little sample may lead to inaccurate results.
5. The test results of this reagent are for clinical reference only
and should not be used as the only basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
comprehensive evaluation of all clinical and laboratory results.
Product Performance Indicators
1. detection limit: inactivated SARS-CoV-2 virus culture was used
in this study, and the lowest detection limit of the kit was
6102TCID50/mL.
2. Using enterprise reference products for testing, the results
should meet the requirements of enterprise reference products.
2.1 Qualified rate of positive reference materials: P1-P5 of
enterprise positive reference materials are positive.
2.2 Qualified rate of negative reference materials: all the
negative reference materials N1-N10 of enterprises are tested
negative.
2.3 detection limit: the reference products L1-L3 and L1 are
negative, and L2 and L3 are positive.
2.4 Reproducibility: J1 and J2 were tested, and they were positive
10 times each.
3. Cross-reaction: Add the following microorganisms and viruses to
the samples with specified concentrations to evaluate their
potential interference to the 2019-nCoV Ag detection program.
Viruses.
| 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. disruptor: Evaluate the potential interference to the test items
of 2019-nCoV Ag, and add the following drugs at the indicated
concentration. The results showed that all kinds of drugs did not
interfere with the detection results of this 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 | 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: No hook effect was observed in the inactivated
culture of 2019-nCoV in the high concentration range of 1.0106
TCID50/mL.
6. Clinical research: Using RT-PCR detection reagent as contrast
reagent, saliva and sputum samples were evaluated respectively. 120
positive and 120 negative samples were selected from each sample
size (RT-PCR detection), and secondary detection of xiu reagent was
used. The results are summarized as follows:
Precautions
1. This product is used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Operate in strict accordance with the reagent instructions and
read the instructions carefully before the experiment.
4. Avoid conducting experiments under severe environmental
conditions (including high concentration corrosive gases such as 84
disinfectant, dust, sodium hypochlorite, acid and alkali or
acetaldehyde). Laboratory disinfection should be carried out after
the experiment.
5. Samples and used reagents should be regarded as potentially
infectious and treated according to local laws and regulations.
6. Reagents shall 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.
Logo interpretation
| 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 |
Basic Information
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
Company profile
Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise
engaged in the research and development, production and operation
of in vitro diagnostic products. The in vitro diagnostic products
developed by the company cover POCT series, microbial series,
biochemical series and immune series reagents and supporting
instruments.
The company has always adhered to the core concept of "fast and
accurate, living up to life", committed to providing society with
excellent products and services, and contributing to the cause of
human health.
