IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
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EASY Line

New Line for Rapid Diagnostic Tests

Rapid Test Product Information & Purchase Order

Method & Sample Line Product Package Info
Microbiology EASY Line EASY Line Typhoid IgG/IgM Antibody Test (Cassette) Tests per Package: 30
Serum Code: 15206-1 Package Format: Cassette (3mm)
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  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

EASY Line Typhoid IgG/IgM Antibody Test is a lateral flow chromatographic immunoassay for the qualitative detection of Typhoid Antibody in serum or plasma sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

EASY Line Typhoid IgG/IgM Antibody Test

Typhoid IgG/IgM Antibody

L1&L2 were inspected, L3 was inspected or was not, L4 was not inspected.

Typhoid fever is an acute infectious disease invasion by Salmonella typhi caused by the digestive tract, typhoid bacilli into the digestive tract through the mouth into the room against intestinal mucosal blood can cause typhoid bacteremia, thereEASY Line Typhoid IgG/IgM Antibody Test fore, very important for early diagnosis of typhoid fever. Diagnosis is based on clinical features mainly typhoid and laboratory examination, Widal test (Widal) is a classical detection methods, and blood culture is still the gold standard. But Widal test positive infections usually appear after 5 ~ 6d, and low positive rate vulnerable to a variety of factors, and false negative and false positive. Blood culture is the most commonly diagnosed typhoid basis, is the gold standard, cultivate a pathogen can be diagnosed. Because bacterial culture a long time, the detection process tedious and affected by many factors, both of which is difficult to achieve the purpose of early diagnosis. However, because the glue gold method, ELISA method were detected Salmonella typhi antigen directly in serum of Salmonella typhi antigen, as long as there is the presence of Salmonella typhi, either dead bacteria or live bacteria, can check out, at the same time without antibiotics interference, early onset can get a positive result, and therefore high sensitivity. Therefore, clinicians should be the correct choice of inspection methods help diagnose typhoid fever.

Test results are read visually without any instrument. For “in vitro” diagnostic use only.

EASY Line Typhoid IgG/IgM Antibody Test is a immunoassay utilizing highly specific reactions between double antigen sandwich for the detection of Typhoid Antibody.

EASY Line Typhoid IgG/IgM Antibody Test is a rapid serum or plasma samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Typhoid Antibody without the of an instrument.

Typhoid fever is acute intestinal infectious disease caused by Salmonella typhi spread through the digestive tract. Clinical features of long-range fever, systemic symptoms, relative bradycardia (pulse rate and body temperature of proportion), hepatosplenomegaly, skin rash and leukopenia Rose. The main complication for intestinal bleeding, intestinal perforation. Source of infection for the patient and those bacteria. Year-round disease, but more common in summer and autumn festival, from July to October each year, is the high incidence of typhoid fever season, and the summer and autumn of people like to eat cold food and flies frequently related activities. Full course are contagious to course of the first two to four weeks maximum contagious. People are generally susceptible to typhoid fever, persistent disease after receive immunity, who rarely sick again. Typhoid fever is generally mild in children than in adults, and is more common in school-age children. Fatality rate is not high, but not typical clinical symptoms, easily misdiagnosed. Typhoid fever is caused by Salmonella typhi infection in the body as a B acute intestinal infectious diseases. At present, our country and the world is still one of the more common infectious diseases in many developing countries. In recent years, due to an increase in light of typhoid and extensive use of antibiotics, the clinical symptoms not typical. Therefore, the early and rapid diagnosis is the key to prevention and treatment of the disease and focus.

The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the sample passes through membrane contains Typhoid antibody to the specific anti Typhoid IgG/IgM antibody, the line turns distinctly red in the test area. The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of Typhoid antibody in the sample, the control line will appear.

The kit contains reagents for 30 tests in cassette (code 15206-1).

Individually packed test devices (cassette)

30

Number of tests

30

Code

15206-1

The test contains a membrane strip coated with anti Typhoid IgG/IgM antibody conjugates on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with Typhoid antigen.

 

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Typhoid IgG/IgM Antibody Test and other commercially available rapid One Step Typhoid Antibody Test. Testing was performed on 1200 samples. All the presumptive positive and negative results were confirmed by the result of hospital.

Test

Substance

EASY Line Typhoid IgG/IgM Antibody Test

Typhoid IgG/IgM Antibody

%Agreement with results of hospital

 

Typhoid-IgG

Typhoid-IgM

Positive Agreement

100%

100%

Negative Agreement

100%

100%

Total Results

100%

100%

%Agreement with commercial kit

 

Typhoid-IgG

Typhoid-IgM

Positive Agreement

100%

100%

Negative Agreement

100%

100%

Total Results

100%

100%

The 1200 clinical samples for Typhoid IgG/IgM Antibody were run using each strip contained within EASY Line Typhoid IgG/IgM Antibody Test by an untrained operator at a Professional Point of Care site. The untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, sample to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested eight times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The results are given below:

Sample

Total number of Determinations

Result

Precision

Negative sample

40

40 negative

>99%

Positive sample

40

40 positive

>99%

Precision sample

40

40 positive

>99%

Analytical Sensitivity

The results are summarized below.

Antibody concentration Cut-off Range

Typhoid(IgG/IgM)

-

+

Negative sample

10

0

L1

0

10

L2

0

10

L3

0

10

L4

10

0

Analytical Specificity

When the sample concentration is below the level of the material shown in the following list, and does not affect the test results.

Name

Concentration

Ascorbic acid

20 mg/dL

Heme

1000 mg/dL

Bilirubin

60 mg/dl

Oxalic acid

1000 mg/dL

Human serum albumin

2000 mg/dL

Triglycerides

500 mg/dL

Cross-Reactivity

A study was conducted to determine the cross-reactivity test, whenother bacteria present in Serum or plasma.

Non Cross-Reacting Compound

The following list of materials does not cause cross-reactivity.

Name

Name

HIV-positive

HCV-positive

Mycoplasma pneumoniae

Chlamydia pneumoniae

Adenovirus

Respiratory syncytial virus package

Influenza virus

EV virus

Streptococcus pneumoniae

Lung Cancer

Chronic bronchitis

Emphysema

The results show that those bacterias in serum or plasma above are all negative.

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