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
Women’s Health EASY Line EASY Line Chlamydia Ag Test (Strip) Tests per Package: 50
Secretion Sample Code: 15204-2 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

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.

The EASY Line Chlamydia Ag Testis a rapid one step screening test for the qualitative detection of Chlamydia Antigen (Ag) in secretion sample. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Chlamydia Ag Test is a profession-performing immunoassay designed for the qualitative determination of Chlamydia Ag in secretion sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

EASY Line Chlamydia Ag Test

Chlamydia Antigen

5 µg/mL was inspected

There are many ways to detect Chlamydia trachomatis, mainly cell culture, molecular biology method PCR, the gold standard method, ELISA method. Cell culture, although the highest sensitivity and specificity, but a long culture period is not suitable for detecting a day; PCR, although the accuracy of the molecular biological methods, high sensitivity, but the higher cost of detection conditions and, is not widely used for the primary hospital; the gold standard method and ELISA method less demanding conditions, general laboratory to meet the conditions, particularly immune colloidal gold technique required a shorter time, within 30 minutes the result. Chlamydia trachomatis detection, immune colloidal gold technique the most popular.

ELISA was also a commonly used laboratory detection methods, the sensitivity and specificity between PCR and molecular biological immune colloidal gold technology. ELISA method has good specificity, high sensitivity, low missed, good reproducibility, sensitivity higher than the immune colloidal gold technique. But time-consuming than the immune colloidal gold technique required three hours about the result. By ELISA assay positive rate of male urethral swab specimens is much higher than the immune colloidal gold technique, it is suggested that two kinds of methods utilize a small sample volume and the urgent need to use the immune colloidal gold technique to detect when the report; specimen volume, the by ELISA. For best male urethral swab specimens and then concentrated to a certain amount detected by ELISA, this will maximize the detection rate. Detection of Chlamydia trachomatis men of great importance for its early diagnosis by ELISA infection.

EASY Line Chlamydia Ag Test is a immunoassay utilizing highly specific reactions between double antibody sandwich for the detection of Chlamydia Antigen.

EASY Line Chlamydia Ag Test is a rapid secretion samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Chlamydia Antigen without the of an instrument.

Chlamydia trachomatis is a microorganism found that it currently has 15 serotypes, different serotypes can cause different diseases. It is divided into three biotypes, namely mice biotypes (biovar mouse), trachoma biotype (biovar trachoma) and lymphogranuloma venereum biotype. After both human diseases.

By indirect immunofluorescence test trace, trachoma biotype was divided into A, B, Ba, C, D, Da, E, F, G, H, I, Ia, J, K14 serotypes, LGV biotypes have L1, L2, L2a, L34 serotypes.

Chlamydia trachomatis is a type of parasitic organisms in the cell size of about 250 ~ 450nm. Chlamydia does not heat quickly lose its infectivity at room temperature, heated to 50°C, 30 minutes to kill. But chlamydia cold, under -70°C can survive for several years. Tetracycline, erythromycin, chloramphenicol inhibit it, and streptomycin, neomycin, it is invalid. Commonly used disinfectants such as 0.1% formaldehyde, 0.5% carbolic acid can be rapidly inactivated Chlamydia.

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 Chlamydia Antigen to the specific Chlamydia 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 Chlamydia Antigen in the sample, the control line will appear.

 

The kit contains reagents for 50 tests in strip (code 15204-2).

Individually packed test devices (strip)

50

Number of tests

50

Code

15204-2

The test contains a membrane strip coated with Chlamydia Ag antigen conjugates on the test line, a goat anti rabbit IgG antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antigen specific to Chlamydia Ag.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Chlamydia Ag Test and other commercially available test kit. Testing was performed on 1200 samples. All the presumptive positive and negative results were confirmed by the result of hospital

%Agreement with commercial kit

 

Chlamydia Ag

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

%Agreement with results of hospital

 

Chlamydia Ag

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

The 1200 clinical samples for Chlamydia Antigen were run using each strip contained within EASY Line Chlamydia Ag 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

CT

-

+

Negative Sample

10

0

100 µg/mL

0

10

50 µg/mL

0

10

5 µg/mL

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

Human mucin

10 mg/mL

Metronidazole suppository

5 mg/mL

Tinidazole vaginal effervescent tablets

5 mg/mL

Miconazole nitrate suppositories

5 mg/mL

Bifonazole ointment

5 mg/mL

Kangfute suppositories

5 mg/mL

M may be set effervescent vaginal tablets

5 mg/mL

Fuyinjie lotion

20 µL/mL

Jieeryin lotion

10 µL/mL

Vaginal moisturizing gel

10 µL/mL

Nonoxynol film

5 mg/mL

Povidone iodine lotion

20 µL/mL

Cross-Reactivity

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

Non Cross-Reacting Compound

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

Name

Name

Name

Calcium acetate Acinetobacter

Candida albicans

D streptococci

Acinetobacter

Proteus

Haemophilus influenzae

Class Streptococcus

G. vaginalis

Branhamella

Feces Streptococcus

Bizarre sex bacilli

Lactobacillus

Staphylococcus aureus

Neisseria meningitidis bacteria

Corynebacterium

Minnesota Salmonella

Streptococcus

Mycoplasma hominis

Klebsiella pneumoniae

Streptococci

UU

Pseudomonas aeruginosa

Hepatitis Streptococcus

 

The results show that those bacterias in the secretion above are all negative.

Chlamydia Rapid Screen Test is a special test kit designed to detect chlamydia infection in urine. This kit is easy to use at home and gives you a high clinical accuracy result in just 15 minutes.

Chlamydia is an infection caused by the bacterium Chlamydia trachomatis. Chlamydia can infect the penis, vagina, cervix, anus, urethra, eye, or throat.

- Tested by laboratories worldwide
- High Clinical Accuracy 
- Detects Chlamydia (Chlamydia Trachomatis) Antigen
- Reliable and fast result in less than 15 minutes
- Safe and easy to use

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