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A rapid test for the qualitative detection of antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma.
For professional in vitro diagnostic use only.
INTENDED USE
The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

DIRECTIONS FOR USE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.
1.Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 L) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below.
To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

A rapid test for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
For professional in vitro diagnostic use only.

Sensitivity
The Malaria P.f/ Pan Rapid Test Device (Whole Blood) has been tested with thin or thick microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f/ Pan Rapid Test Device (Whole Blood) is >99.9% relative to microscopy.
For Pan:
Relative Sensitivity: >99.9% (158/158) (97.6%100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93%100.0%)*
Specificity
The Malaria P.f/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria P.f/ Pan antigens in whole blood. The results show that the specificity of the Malaria P.f/ Pan. Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy.
Relative Specificity: >99.0% (324/327)(97.3%99.8%)*
Accuracy: >99.4%(535/538)(98.3%99.8%)*
* 95% Confidence Interval

Total Results211327538
Note: The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan-malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.

Troponin I (CTnI) One Step Rapid Test Kit
(Whole blood/serum/plasma)
Product description

Product name:
CTnI One Step Troponin I Rapid Test Kit
Specification:
Lateral-flow Immunofluorescence Chromatographic Assay 10 pcs, 25 pcs, 50 pcs, 100 pcs/box, or customized
Type:
Cassette
MOQ:
10,000 PCS
Analytical Range:
1.0~50ng/ml (Whole Blood); 0.1~50ng/ml (Serum/Plasma)
Specimen:
Human serum/plasma/whole blood
Manufacturer:
Hangzhou Laihe Biotech Co., Ltd.
2.Clinical significance
(1)Diagnosis of various chest pain
(2)Foundation of ACS diagnosis and risk stratification
(3)Best markers for ACS prognosis
(4)An aid in the diagnosis of myocardial infarction (injury)
(5)Can improve clinical, economic and operational outcomes

In One Cup Cup Multi-drug One Step 2-15 Drug Test Simple Cup (Urine) CE Qualified (MOP/MET/KET/AMP/BAR/BUP/BZO/COC/COT/MDMA/THC/MTD/OPI/PCP/TCA)

Diagnostic Kit Pouches are made out of multi-layer laminated Polymeric film. The laminate consists of a reverse-printed polyester film laminated to aluminium foil or metalized polyester film. This helps in giving high air and moisture barrier to the packaging. The bottom layer of this laminate is a polyethylene film which helps in heat sealing, closing the pouch, and securing the contents of the package. Customisation in sizes, composition of films used in the laminate and branding is possible. The packaging material is supplied in roll form and can be easily run on a form-fill-seal (ffs) machines for online packing of diagnostic kits.

Significant Features:
Photo Quality Multicolour Printing is possible

Customised Sizes can be made

Aluminium foil or Metalized Polyester barrier layer options are available.