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
Infectious Diseases EASY Line EASY Line Tuberculosis (TB) Test (Strip) Tests per Package: 50
Serum Code: 15203-2 Package Format: Strip (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

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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.

The EASY Line Tuberculosis (TB) Test is a rapid one step screening test for the qualitative detection of Tuberculosis Antibody in serum or plasma. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

Tuberculosis Test is a profession-performing immunoassay designed for the qualitative determination of Tuberculosis Antibody in serum or plasma at the following cut-off concentrations:

Test

Cut-off

TB Ab

1:2000 was inspected

Tuberculosis is a serious harm to human health, chronic diseases, mainly based on the clinical diagnosis of tuberculosis, chest X-ray and sputum bacteriology, although bacteriological diagnosis of TB diagnosis is the "gold standard", but there are anti-smear lower rates of acid staining, although bacterial culture can improve the detection rate, but also less than 50% but need 6-8 weeks to report the results, it is difficult to make an early diagnosis of TB, can not meet the clinical needs. Therefore looking for a quick, accurate diagnostic methods to improve TB detection rate is important. We apply the joint TB serological antibody detection methods: dot immunogold filtration assay (TB-DOT), the immune chromatography (TB-IgG) and enzyme-linked immunosorbent assay (TB-SA) 3 tuberculosis antibody combined detection method explore the positive rate of tuberculosis patients, and compared with non-tuberculosis lung disease and healthy people to observe its diagnostic value.

The results showed that 3 TB detection specificity 93.70% ~ 97.70%, individual testing positive rate was 61.90% ~ 71.40%, together with a positive rate of two and three, respectively 91.40% and 94.10%. Due to the different detection methods tuberculosis antigens and antibodies kit manufacturer choice, so we chose three different methods of tuberculosis antibody reagents to detect multi-faceted, results showed significantly higher positive rate of smear and culture. But tuberculosis antibody test as a means of checking the humoral immune detection of tuberculosis Bureau of surviving in a certain antibody titers in the development and improvement of cured TB have different performance.

TB antibody test is simple, rapid, sensitive, inexpensive diagnostic method, a method to detect tuberculosis combined immune three laboratories a rapid diagnosis of tuberculosis can be an important indicator of clinical TB.

 

EASY Line Tuberculosis (TB) Tests is a immunoassay utilizing highly specific reactions between double antigen sandwich for the detection of Tuberculosis Antibody.

EASY Line Tuberculosis (TB) Tests is a rapid serum or plasma samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Tuberculosis Antibody without the of an instrument.

Mycobacterium tuberculosis (M. tuberculosis) referred to as Mycobacterium tuberculosis (tubercle bacilli). As early as 1882, the German bacteriologist Koch (Robert Koch ,1843-1910) had proved Mycobacterium tuberculosis pathogen. The bacteria may invade the body tissues and organs, but the most common lung infection. With the continuous development of anti-TB drugs to improve the health and living conditions, TB morbidity and mortality once dropped significantly. After the 1980s, as a result of AIDS and drug-resistant strains of Mycobacterium tuberculosis, the application of immunosuppressants, drugs, poverty and population movements and other factors, the global TB epidemic suddenly deteriorated. According to WHO statistics, there are people in the world about every 3 1 person infected with Mycobacterium tuberculosis, in some developing countries of Mycobacterium tuberculosis in adults carry up to 80%, of which about 5% to 10% of the carriers can develop active TB.

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 Tuberculosis antibody to the specific Tuberculosis antigen, 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 Tuberculosis antibody in the sample, the control line will appear.

The kit contains reagents for 50 tests in strip (code 15203-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15203-2

The test contains a membrane strip coated with Tuberculosis antigen 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 Tuberculosis antigen.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Tuberculosis (TB) Tests and other commercially available rapid One Step Tuberculosis 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 Tuberculosis (TB) Tests

Tuberculosis Antibody

%Agreement with results of hospital

 

TB

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

%Agreement with commercial kit

 

TB

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

The 1200 clinical samples for Tuberculosis Antibody were run using each strip contained within EASY Line Tuberculosis (TB) Tests 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

TB

-

+

Negative sample

10

0

1:500

0

10

1:1000

0

10

1:2000

0

10

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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