Jiangsu Bioperfectus Technologies ⚫ Operate strictly according to the instructions for use.

⚫ Operate strictly according to the testing procedures of the biosafety laboratory of

infectious diseases.
Dengue NS1 Ag Rapid Test Kit ⚫ Wash hands thoroughly before and after using the device.
⚫ Wear protective clothing such as laboratory coats, disposable gloves and eye
INSTRUCTIONS FOR USE protection while handing samples.
⚫ Do not use the test device out of expiration date or damaged.
SC20101W-1T/20T/25T/50T 1T/20T/25T/50T ⚫ Products are disposable. Do not reuse.
⚫ Do not mix or interchange different samples.
For In Vitro Diagnostic Use Only ⚫ Do not mix use devices from different batches.
05.2023 ⚫ Read the results within the specified time. If the read time is too short or too long,
For Professional Use Only
the results will be inaccurate. To ensure the accuracy of the interpretation, do not read
Jiangsu Bioperfectus Technologies Co., Ltd. in the dim place.
⚫ The reagent and specimen are infectious and should be disposed in accordance with
No. 837, Yaocheng Avenue, 225300 Taizhou City, Jiangsu Province,
local regulations.
PEOPLE'S REPUBLIC OF CHINA.
⚫ Additional controls could be carried out according to guidelines or requirements of
www.bioperfectus.com local, state and/or federal regulations or accrediting organizations.
MedNet EC-REP GmbH ⚫ Do not eat, drink, or smoke in the laboratory working area.
Borkstrasse 10·48163 Muenster·Germany
8. Sample type
1. Intended Use Human serum and plasma.
For the qualitative testing of Dengue NS1 antigen in human serum or plasma samples.
9. Sample Preparation
2. Kit Components ⚫ All sample collection/pretreatment procedures should strictly follow the local
SC20101W- SC20101W- SC20101W- SC20101W- guidelines.
Cat. No. ⚫ Collect samples in sterile tubes.
1T 20T 25T 50T
Cassette 1 cassette 20 cassettes 25 cassettes 50 cassettes ⚫ Store specimens refrigerated (2-8℃) for no more than 7 days. Store at -20℃ or
Instructions colder for long-term storage.
1 pc 1 pc 1 pc 1 pc
for use ⚫ Ensure that all applicable regulations for the transportation of etiologic agents are
Pipette 1 pc 20 pcs 25 pcs 50 pcs satisfied. Transport clinical specimens refrigerated at 2-8℃.
NOTE: Components from different kit and batch can’t be used interchangeably.
10. Procedure
3. Storage 1) Read the instructions for use carefully before beginning the test.
⚫ The kit should be stored at 4℃-30℃ before expiration date indicated on the outer 2) Restore the test card, assay buffer and sample to room temperature before
box. testing. Thoroughly mix the sample before use.
⚫ Store kit in a location out of direct sunlight and out of reach of children. 3) Remove the test card from the foil pouch and place it horizontally on the
⚫ The kit can be directly transported at ambient temperature of -20℃~45℃. table. Record the sample information.
⚫ When transporting or storing the kit, avoid the exposure to high temperature (over 4) Add 70μL serum/plasma with a pipette or 3 drops of serum/plasma with the
45℃) for a period longer than 1 week. provided pipet into the sample well vertically.
5) Read result 15 minutes after the buffer is added. DO NOT interpret result
4. Materials and Devices Required but Not Provided after 30 minutes.
⚫ Biosafety cabinet. NOTE:
⚫ Vortex mixer. * DO NOT move the cassette during the test.
⚫ Adjustable pipettes. *Appropriate increase the volume of the assay buffer if the sample is viscous.
⚫ Disposable pipette tips with filters. *The shades of test line (T line) do not affect the result. As long as the test line is
⚫ Disposable powder-free gloves. colored, it can be judged as positive.
⚫ Biohazard container *When an exception occurs, retest the sample is recommended.
⚫ Timer *Discard all the test pieces into the waste bag/biohazard container in accordance with
⚫ Disposable gloves the applicable local regulations.
⚫ Pencil or pen
NOTE: Please ensure that instruments have been installed, calibrated, checked and 11. Limitations
maintained according to the manufacturer’s instructions and recommendations. ⚫ For the qualitative testing of dengue NS1 antigen in human serum or plasma only.
Cannot be used as a quantitative reagent.
5. Background Information ⚫ Due to the limitation of the reaction principle, false negative results may occur in
Dengue fever is an acute infectious disease caused by dengue virus, which is mainly rare occasions. It may cause by the low amount of the objective antigen. In this situation,
transmitted by Aedes aegypti and Aedes albopictus. Cases are commonly found in the researchers should pay more attention to the negative results and analyses the results
tropical and subtropical countries and regions. Dengue virus is a single-strained, combined with other clinical test results. Repeat the test with a new device is suggested.
positive-sense RNA virus, belonging to the Flaviviridae Family. The core of the virus ⚫ Biologic false-positive is inevitable in some occasions because of the non-
consists of 20 symmetrical particles of RNA and protein. The outer layer consists of specificity results in high sensitivity immunological experimental system.
two glycoproteins. The viral genes encode three structural proteins (nucleocapsid ⚫ The test result is used for clinical reference only, definite diagnosis or excluded
protein C, membrane protein M, envelope protein E) and seven nonstructural proteins cases is undesirable. The test results should combine with the clinical examination,
(NS1, NS2a, NS2b, NS3, NS4a, NS4b, NS5). In the early stages of the infection, NS1 medical history and other test results for diagnosis purpose.
exists in a form of glycoprotein in the sera of infected patients. NS1 antigen can be ⚫ The volume of added samples shall strictly comply with the instructions for use,
detected within 1~9 days after onset after the primary or secondary infection. Normally, otherwise inaccurate results may occur.
IgM antibody can be detected within 5~10 days after the primary infection. IgG
antibody can be detected after one week and may maintain for several years or even the 12. Result Interpretation
whole life. In the secondary infection, specific IgG antibody levels would rise within
1~2 day after the onset. Thus, dengue virus NS1 can be used as a sign for the detection Two colored lines appear,
of early acute infection. Positive one at the T area and the other
This kit is used only for the detection of patients with clinical symptoms of dengue at the C area.
fever, and the results are only for clinical reference.

6. Product Description
This product is based on immunochromatographic technology. The detection area of
Only one colored line appears
the strip has a test line (T line) and a control line (C line). Goat anti-rabbit IgG antibody Negative
at the C area.
and NS1 antigen specific antibody is coated on the C line and T line, respectively.
Rabbit IgG antibody and another NS1 antigen specific antibody are coated on the
conjugate pad.
When starting the test, the sample will be added into the sample well on the cassette.
After mixing with the colloidal gold-labeled antibody on the conjugate pad, the sample No colored line appears at the
will then flow onto the nitrocellulose membrane. If dengue NS1 antigen is present in Invalid C area even if a colored line
the sample, the antigen will form a complex with the colloidal gold-labeled antibody appear at the T area
coated on the conjugate pad. The complex will be captured by the NS1 antigen specific
antibody coated in the T line area. In this case, a visible T line will appear on the
detection area as the presence of dengue NS1 antigen. If dengue NS1 antigen does not 13. Performance Characteristics
present in the sample or the antigen concentration is lower than the detection limit of ⚫ Limit of Detection (LOD)
this method, only a C line will be visible. The limit of detection of the kit is determined by testing varied concentrations of
plasmodium diluents for 20 times, and repeat the whole process for 3 batches. The level
7. Warnings and Precautions with a positive detection rate of 95% was set as the limit of detection.
⚫ The test devices are for in vitro diagnostic and professional use only. Serotype I II III IV

www.bioperfectus.com
Bioperfectus Technologies Dengue NS1 Ag Rapid Test Kit Version1.5 Issue Date:May 2023
 2.5x103 5x103 1x102 5x102
LOD
PFU/ml PFU/ml PFU/ml PFU/ml
The detection limit of dengue serotype I, II, III, IV is 2.5x103 PFU/ml, 5x103 PFU/ml,
1x102 PFU/ml and 5x102 PFU/ml, respectively.
⚫ Diagnostic Sensitivity and Specificity
Dengue NS1 Ag Rapid Test Kit has been tested with Dengue positive and negative
clinical samples confirmed by highly praised comparator reagent. The results are as
followed:
Comparator reagent
Bioperfectus
Positive Negative Total
Positive 350 5 355
Negative 10 768 778
Total 360 773 1133
Sensitivity: 97.22%, 95%CI: 94.96%～98.48%
Specificity: 99.35%, 95%CI: 98.49%～99.72%
Accuracy: 98.68%, 95%CI: 97.83%～99.20%

⚫ Analytical specificity
The following cross reactivity microorganisms have no impact on the assay.
Potential cross-reacting
No. Type Positive/Total
microorganisms
1 Inactivated Yellow Fever 0/5
2 Inactivated Chikungunya 0/5
3 Inactivated Zika 0/5
4 Inactivated Japanese encephalitis 0/5
5 Virus Inactivated Hepatitis B 0/10
6 Inactivated HIV 0/10
7 Inactivated Influenza A 0/10
8 Inactivated Influenza B 0/10
9 Inactivated Rubella 0/5
10 Inactivated Treponema pallidum 0/5
Bacteria
11 Inactivated Borrelia burgdorferi 0/5
12 Inactivated Toxoplasma gondii 0/5
13 Inactivated Chagas 0/5
Parasites
14 Inactivated Malaria Pf 0/10
15 Inactivated Malaria Pv 0/10
The cross-reactivity of Bioperfectus Dengue NS1 Ag Rapid Test Kit with other relevant
microorganisms, including bacteria, viruses and parasites were demonstrated on assay
performance. In these studies, those specimens did not react with the Bioperfectus
Dengue NS1 Ag Rapid Test Kit.

⚫ Interference substances
The following potentially interfering substances have no impact on the assay.
Potential interfering
No. Type Concentration
substances
1 Hemoglobin 2.5mg/mL
2 Compounds Triglyceride 30mg/dL
3 Bilirubin 12000mg/L
4 Rheumatoid factor Rheumatoid factor ≤300IU/mL
5 Autoimmune antibodies Human anti-mouse antibody ≤500IU/mL
The effects of potential interference substances were characterized on assay
performance. Potential sources of interference including Positive titers of rheumatoid
factor, Positive titers for other autoimmune antibodies were investigated. In these
studies, those specimens did not interfere with the Bioperfectus Dengue NS1 Ag Rapid
Test Kit.
⚫ Precision
Repeatability and Reproducibility were evaluated by within or between batches assay
conducted by different operators at different sites. There was no statistical difference
during the evaluations.

14. Appendix
Index of Symbols
Authorized representative in the
CE certification
European Community
In vitro diagnostic Medical
Use-by date
device
Manufacturer Date of manufacture

Catalogue number Temperature limit

Consult instructions for use Contains sufficient for <n> tests

Batch code Do not reuse

Keep away from sunlight This side up

15. Contact and Support

For more information about Bioperfectus Technologies, please visit our website at:
http://www.bioperfectus.com or contact at E-mail: info@bioperfectus.com
For detailed programming instructions regarding the use of the Bioperfectus
Technologies Dengue NS1 Ag Rapid Test Kit, please contact our Technical Support at
E-mail: support@bioperfectus.com

www.bioperfectus.com
Bioperfectus Technologies Dengue NS1 Ag Rapid Test Kit Version1.5 Issue Date:May 2023