(FOR REEARH UE ONLY. DO NO UE I IN LINIAL DIAGNOI!) hlamydia rachomatis Antigen Rapid est Kit atalog No: E-HD-021 20 his manual must be read attentively and completely before using this product. If you have any problems, please contact our echnical ervice enter for help. Phone: 240-252-7368(UA) 240-252-7376(UA) Email: techsupport@elabscience.com Website: Please kindly provide us the lot number (on the outside of the box) of the kit for more efficient service. opyright 2017-2018 Elabscience Biotechnology Inc. All Rights Reserved
est principle his kit applies the Gold Immunochromatography (GIA) method as its principle. his kit is composed of monoclonal antibodyⅠimmobilized nitrocellulous (N) membrane, olloidal gold conjugated monoclonal antibody Ⅱ and other supplementary reagents. he detection zone of nitrocellulose membrane was coated with monoclonal antibodyⅠ, and the control zone was coated with mouseanti-goat polyclonal antibody. he polyester film was pre-coated with gold-labeled monoclonal antibody Ⅱ to be used as the gold pad. If there is a certain concentration of antigen in sample, it will combine with gold-labeled natural monoclonal antibody Ⅱ and form a gold-labeled monoclonal antibody Ⅱ- antigen complex. he complex will then move along the detection card and react with the monoclonal antibodyⅠand form a gold-labeled monoclonal antibody Ⅱ- antigen- monoclonal antibodyⅠcomplex. he excessive colloid gold conjugate will combine with mouse-anti-goat polyclonal antibody to form a complex precipitation line. here will be two visible lines appear if the sample contains antigen, while there will be only one control line appears with no test line. he quality control area ( line) on the detection card is standard reference to determine whether the chromatography is normal and whether the detection system is effective. he red line should appear under all condition. Otherwise the detection result is considered invalid and re-test will be required. Kit components Item pecification Detection card 20 Plastic Extraction ube 20 Lysis olution A 1 vial Lysis olution B 1 vial Dacron swab 20 Manual 1 copy Requirements of sample he quality of sample obtained is extremely important. Detection of hlamydia requires a rigorous and thorough collection technique which provides active cellular tissues rather than just secretion. 1. For female endocervical samples: (1) Use only Dacron tipped sterile swabs. It is recommended to use the swab supplied by the kits manufacturer. wabs with cotton tips are not recommended. (2) Before sample collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard. With the swab, insert into the endocervix and pass the squamocolumnar junction until most of the tip is no longer visible. his will permit acquisition of columnar or cubical epithelial cells which are the main reservoir of hlamydia organism. Firmly rotate (clockwise or anticlockwise) the swab in a circle and stay for 5-10 sec without contamination with exocervical or vaginal cells. (3) Put the swab into the extraction tube, if the test may be run immediately. 2
2. For male urine samples: (1) ollect the first urine (approximately 15-30 ml) in the morning. he maximum of antigens can be detected from the first urine in the morning. (2) ample should be stored 24 hours at 2-8, if immediate testing is not allowed. (3) hake and mix the sample, 10 ml sample is drawn into centrifugal tube with 10ml distilled water, centrifugate the mixture at 3000 rpm for 15-20 min. (4) Discard the supernatant carefully. urn over the centrifugal tube, absorb the residual urine with absorbent paper. Assay procedure 1. Read the manual carefully before detection. he reagent and sample should be adjusted to room temperature (15 to 30 ) before use. ear the aluminum foil bag of the detection card and take out the detection card, and put it on a smooth, clean table. 2. Acquire the antigen according to the sample type. Preparation for female endocervical samples: (1) Add 8 drops of Lysis solution A into the extraction tube vertically. Immerse the sample swab into the extraction tube. queeze the tube and twirl the swab for 15 times. hen keep the swab in the extraction tube for 2 min. (2) Add 8 drops of Lysis solution B into the same extraction tube. Deposit may be produced in the mixture. queeze the tube and twirl the swab for 15 times. hen keep the swab in the extraction tube for one minute. he solution will be brown if the swab with blood. Wring all extractive from swab and discard the swab. Finally, cover the extraction tube with a filtration tip. Preparation for male urine samples: (1) Add 9 drops of Lysis solution B into the tube. hake to mix well (use vortex mixer if necessary). ransfer the mixture from centrifugal tube to extraction tube, add 8 drops of Lysis solution A, and squeeze the wall of tube 15 times and stay for 1 min. (2) Dispense 3 drops of extracted samples from extraction tube to the sample well() on the test cassette. (3) Read the result within 10-20 min. Do not interpret the result after 20 min. 3
Judgment of result 1. Positive: red line appears in both test line () and control line (). 2. Negative: red line only appears in control line (). 3. Invalid: no color line appears in control line (). It indicates that the operation is wrong or the detection card is invalid, please carry out another detection. Negative Positive Invalid Interpretation of results Negative result indicates there is no antigen detected in samples, while positive result means the opposite. Any positive result should be determined combined with clinical information. Limitations of this test method his product is for qualitative detection antigen from endocervical or endourethral swab samples only, which cannot give results about the concentration of antigen in samples and the detection effect for other samples is still unclear. Product performance index esting the national reference should conform to the requirements of national reference, testing the enterprise should meet the following requirements: 1. 10 positive reference should be tested all positive. 2. 20 negative reference should be tested all negative. 3. he minimum detection limit reference (L1, L2, L3, L4) should be tested all positive, L5 should be negative. 4. est precision reference for 10 times, variable coefficient (V%) of absorbance (A) is 15%. 4
Notes 1. he test temperature should be kept constant. Avoid of operating under high temperature condition. 2. he detection card should be adjusted to room temperature after removed from the refrigerator before opening. 3. he opening detection card should be used as soon as possible so as not to be invalid because of moisture. 4. he result should be read within 20 min. 5. omponents from different batches and kinds of kit cannot be mixed. Do not mix reagents with other producers. torage and valid period torage: tore at 2-30 with dry condition. Valid Period: 1 year, production date is on the packing box. opyright 2017-2018 Elabscience Biotechnology Inc. All Rights Reserved 5