Torch Igm Rapid Combo Test Device

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.

Multi-drug one step 2-15 drug test device
(urine/saliva)
1.Product description
15.Png
20170120153542.Png
Give a rapid diagnosis for reference to help in hospitals & clinics, rehabilitation centers, diseases control & prevention centers, military recruiting, high-risk group census, physical examination and some related special industries.
Urine or saliva specimen to choose, easy specimen collection
Instant result in 5 minutes
Ce marked


Valid for 24 months. Store at 2-30,


2.Features
-choices: urine or saliva specimen for multi-drug test
-test more than 2 drugs in one time, distinct c/t lines
-customized sensitivity, printing color and packing
-accurate, specific, quiet, stable, convenient
-latest production
-best seller in china domestic market, competitive quality and price
-easy payment and shipment

A rapid, one step test for the qualitative detection of Amphetamines in human urine.

For healthcare professionals including professionals at point of care sites

For professional in vitro diagnostic use only.

A drug-free urine pool was spiked with Amphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
AMP Concentration (ng/mL)Percent of CutoffnVisual Result
NegativePositive
00%30300
500-50%30300
750-25%30237
1,000Cutoff30921
1,250+25%30129
1,500+50%30030

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

Product name: hCG One Step Pregnancy Test Kit,FSH One Step Menopause Rapid Test Kit ect.
Specimen: Urine
Format: Strip/cassette/midstream
Specification: 25pcs, 40pcs, or customized
MOQ: 10,000 pcs
Accuracy: > 99%
Storage: 4-30°C
Valid for: 24 months

(1)The One Step Drug Screen Test Panel (Urine) is an immunoassay based on the principle of competitive binding.Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.

(2)During testing,a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody coated on the particles. The antibody coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug strip. The colored line will not form in the test line region if the drug level is above its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles.

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.

Product name:POCT PCT/CRP/hsCRP Rapid Test Kit
Specification: 10 pcs, 25 pcs, 50 pcs, 100 pcs/box, or customized
Specimen: Whole blood/serum/plasma
Type:Cassette
MOQ: 10,000 PCS
Specimen:Human serum/plasma/whole blood
Corollary machine: POCT Analyzer blood diagnostic machine FA-LF100B
2.Application
PCT:
Sepsis Monitoring
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Sepsis Diagnosis
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(Note: The cut-off value 2.0ng/ml is for reference only. Clinical departments shall adjust according to patient's situation.)
CRP/hsCRP
- Differential diagnosis of virus infection and bacterial infection
- CRP relating with cardiovascular disease (CVD)
- Accurate early diagnosis in pregnant women with amniorrhexis premature delivery and ch

hsCRP
< 1.0 mg/L
Cardiovascular disease risk: Low risk
1.0-3.0 mg/L
Cardiovascular disease risk: Moderate risk
Anti-inflammatory therapy is recommended.
> 3.0 mg/L
Cardiovascular disease risk: High risk
Anti-inflammatory and antithrombotic therapy is recommended.



CRP
< 10 mg/L
Less possibility of bacterial infection or bacterium are eradicated
10-25 mg/L
Virus infection signal
When course is short, bacterial infection is possible. Re-check after hours.
25-50 mg/L
Virus/bacterial infection signal
50-100 mg/L
Usually bacterial infection
Virus infection is uncommon.
> 100 mg/L
Bacterial infection signal
Less possibility of virus infection

CTnI One Step Troponin I Rapid Test Kit
(Whole blood/serum/plasma)
1.Product description
Introduction:
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.
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
Principle
Insert the sample cassette into Immunofluorescence Quantitative Analyzer. The detection system will scan the markers and bond zone to gain optical signals, and then analyze the signals to get the concentration of the tested sample.
Storage
Valid for 24 months under 4-30 °C with aluminum foil bag packing. Once opened, the cassette is valid for 1 hour.

2.Application
Clinical Laboratory, ED, ICU, CCU, Respiratory Department, Cardiology Department, Pediatrics Department, Surgery Department, Hematology Department, etc.