Lateral flow rapid testing system (Rapid Test)-1

1. Device: white plastic cassette.

2. Reaction window: to show the results.
- C: control line, band to identify an
appropriate immuno-reaction of the kit
- T: test line, band to qualitatively detect
materials
3. Sample well: to load specimens like serum, urine, blood, dissolve
swaps, feces, etc.
4. Disposable pipette or dropper
5. Silica gel as desiccant to maintain dryness.
6. Instruction manual
Lateral flow rapid testing system (Rapid Test)-2
1. Plastic basement: support all components.
2. Sample pad: firstly contacted with samples and compensate them to make an appro-
priate assay condition.
3. Conjugate pad: contain antigen- or antibody-coupled gold.
4. Nitrocellulose membrane: micro-porous matrix to flow liquid solution. Matrix to be
immobilized analytic proteins.
5. Absorbance pad: absorb the reaction liquid to be flowed & finished immuno-reaction.

Sample pad Absorbance pad

Conjugate pad Nitrocellulose

membrance

Plastic basement (Support)

T C
Capture 1 Capture 2
 Assay principals of Rapid Test
1. Main principle: immunochromatographic assay.
(interactions of capture and conjugate)
2. Capture: immobilized antigens or antibodies onto N/C mem-
brane.
3. Conjugate: antigen- or antibody-coupled colloidal gold
4. Driving force: micro-porous capillary motion

HB
s
Flow C
NS1 (+) sample
T
G
G

G Colloidal gold
Mouse anti-dengue
NS1 mAb
NS1 Ag
T C
Anti-dengue Anti-mouse IgG
NS1 Ab
Assay methods and analysis of Rapid Test
• Assay procedure: Easy
1. Load 3 drops of sample into Sample well.
2. Wait for 3 ~ 20 minutes.
3. Read the results by naked eye.
• Analysis in general: Very simple
1. Negative: no band in the region of test line.
2. Positive: band expression in the T region.
3. Invalid: no band in the C region.
Negative Positive Invalid

C C C C

T T T T
Dengue fever
▸ Systemic and Dynamic disease, the clinical presentation depending on the different phases of the disease.
▸ After a person being bitten by an infected mosquito (usually 2-7 days), the illness begins abruptly and will be followed by
3 phases which is the
▹ febrile,
▹ critical and
▹ recovery phase.
▸ Patients may arrive in the clinic or emergency department with nonspecific complaints.
▸ Most times, the diagnosis will be suspected during the gathering of the history.
▸ It is important to ask about
▹ recent travel,
▹ the constitutional symptoms and
▹ if patient live in an outbreak area.
▸ The key is to obtain a good history and suspect the diagnosis early.
▸ After the history taking and clinical examination completed and the diagnosis of suspected dengue case is established,
▸ A confirmation test such as COMBO rapid test kit for NS1, IgM and IgG should be performed.
• An infected person experiences the acute symptoms of dengue when there is a high level of the virus in the
bloodstream.

• As the immune response fights the dengue infection, IgM and IgG antibodies are released in the blood and
lymph fluid, where they recognize and neutralize the dengue virus and viral molecules.

• The immune response eliminates the virus leading to recovery.

ACCO DENGUE IgG/IgM
– NS1 Ag COMBO TEST
KIT
Properties
 Specimen : Whole Blood, Serum or Plasma
 Detect both dengue virus antigen (NS1) and
dengue antibodies (IgG/IgM)
 Rapid Result (15-20min) and clear background
 Sensitivity & Specificity > 95% *Buffer storage: Please
close the buffer cap after
 Shelf Life : 24 months after manufacturing date usage and keep it in the
 Storage : Stored at 2-30 °C in sealed pouch box of the test kit.
NS1 Ag Device
Dengue IgG/IgM Device
INTENSITY LEVEL OF NS1 TO BE CONSIDERED POSITIVE (4.00 – 1.00)
INTENSITY LEVEL OF IgG TO BE CONSIDERED POSITIVE (4.00 – 1.00)
INTENSITY LEVEL OF IgM TO BE CONSIDERED POSITIVE (4.00 – 1.00)
INTENSITY LEVEL OF IgG/IgM TO BE CONSIDERED POSITIVE (4.00 – 1.00)
 REFERENCE TABLE OF RESULTS AND ITS INTERPRETATION
DENGUE RESULTS

DENGUE IgG/IgM DENGUE INTERPRETATION

IgM IgG NS1 Ag

+ - + Acute early dengue infection

+ - - Primary infection

+ + - Repeated dengue infection

+ + + Acute dengue infection, repeated infection

- - + Acute primary dengue, early phase

- - - Negative for dengue infection

- + + Early dengue infection, repeated infection

- + - Past infection
Precaution
▸ For in-vitro diagnostic use only. Do not reuse the test device.
▸ Do not use the kit after the expiration date. Do not freeze the kit.
▸ Humidity may decrease the stability of reagents. Please carry out the test
immediately after removing the device from the foil pouch.
▸ Wear protective gloves while handling samples and wash hand thoroughly
after the test.
▸ Disposed gloves, swabs, test tubes and used strips properly after the test
in accordance with Good Laboratory Practice (GLP)
▸ Do not eat or smoke while handling specimens.
▸ Decontaminate and dispose of all specimens in a biohazard container.
POTENTIAL PROBLEM/TROUBLESHOOTING
1. No flow of the sample and buffer solution
- Please make sure the drops of the blood sample is accurate
- Add 1 to 2 more extra drops of buffer if the sample is too thick
- If the solution is still not moving, do try another set of RTK.
- Keep defective RTK for exchange

2. No control band
- The RTK unit is defect
- Please use another set of RTK
- Keep defective RTK for exchange

3. Buffer is cloudy or changed colour

- The buffer might be contaminated
- Please use another set of buffer
- Keep defective buffer for exchange *Do contact us for troubleshooting and
replacement of product.
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