N.Gonorrhea Antigen Rapid Test Card,SPAN_specification/price/image

Gonorrhea Antigen Rapid Test Card

INTENDED USE

PRINCIPLE

INTRODUCTION

KIT COMPONENTS

COMPONENTS	DETAIL	QUANTITY
Individual packed test devices	Each device contains a strip with colored conjugates and reactive reagents precoated at the corresponding regions.	20 pieces
Lysis Buffer A	Main Ingredients: NaCl , NaOH, and purified Water	7ml*1 bottle
Lysis Buffer B	Main Ingredients: NaCl , sodium Azide , and purified Water	7ml*1 bottle
Plastic Extraction Tube	For specimens preparation use	20 pieces
Dacron swab	For specimens collection	20 pieces
Package Insert	For operation instruction	1 pieces

MATERIALS REQUIRED BUT NOT PROVIDED

STORAGE AND VALIDITY

SPECIMEN COLLECTION

For female endocervical specimens:

Use only Dacron or Polyester tipped sterile swabs. It is recommended to use the swab supplied by the kits manufacture. Swabs with cotton tips are not recommended
Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard .The swab should be inserted into the endocervical cannal, past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cubical epithelial cells which are the main reservoir of gonorrhea organisms. Firmly rotate (clockwise or anticlockwise) the swab in a circle and stay for 10 seconds without contamination with exocervical or vaginal cells

For male urethral specimens:

Standard Dacron tipped sterile swabs should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection
Insert the swab into the urethra about 2-4cm; firmly rotate (clockwise or anticlockwise) a circle and stay for 10 seconds , withdraw it, and place it into the extraction tube, if the swab may be tested immediately. If not, place the specimen into a dry transport tube for transport and storage. The swabs maybe stored for 4-6 hours at room temperature (15-30°C) or 24-72 hours at 2-8°C, freeze is forbidden. It is strongly recommended that test the specimen immediately after collection.
All specimens should be brought back into room temperature of 15-30°C before testing.

PROCEDURE

Read the entire procedure carefully prior to testing. Bring tests, specimen and buffer to room temperature (15-30°C) before use.
Do not open the foil pouch until ready to perform the test
Place the tests on a clean and level surface
Extract gonococcal antigens according to difference specimens

Added 5 drops of Lysis buffer A into the extraction tube vertically. Immerse the specimen swab into the extraction tube. Squeeze the tube and twirl the swab 15 times. Then keep the swab into the extraction tube for 2 minutes.
Added 5 drops of Lysis buffer B into the same extraction tube. Deposit may be produced in the mixture. Squeeze the tube and twirl the swab 15 times. Then keep the swab into the extraction tube in one minute. The solution will be brown if the swab with blood. Squeeze and discard the swab. Finally, cover the extraction tube with dropper.

Dispense 2 drops of extracted samples from extraction tube to the sample well(S) on the test cassette
Read the result within 10-15 minutes. Positive result shall be read within 10 minutes, negative result shall be read within 15 minutes. Do not interpret the result after 15 minutes

INTERPRETATION OF RESULTS

POSITIVE RESULT:

NEGATIVE RESULT:

INVALID RESULT:

NOTE:

LIMITATIONS OF THE TEST

Read the entire procedure carefully prior to testing, incorrect performance will lead to incorrect results.
The Test Kit is for professional in vitro diagnostic use, and should only be used for the qualitative detection of gonococcal antigens.
As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
This kit is intended for use as an aid in the diagnosis of neisseria gonorrhoeae infection
Only Dacron or Polyester swab can be used to collect endocervical samples, and the kit is with Dacron swabs
Do not interchange or mix reagents from difference lots

PERFORMANCE CHARACTERISTICS

Positive Coincidence Rate:100%
Negative Coincidence Rate:100%
Analytical Sensitive：The Detection value of gonococcal antigens should be higher than 5x104 in each specimen.
Analytical Specificity: Compared with difference kinds infection factors and the test result are negative.
Intra Batch Discrepancy: The test results are same in one batch
Inter Batch Discrepancy: The test results are same in difference batch

PRECAUTIONS

For single use only
For professional in vitro diagnostic use only.
The specimen dilution buffer contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. Do not drink or smell it.
Do not use the devices when the package damaged
Do not interchange or mix reagents from difference lots
Do not use after the expiration date indicated on the package
Do not touch membrane before performance
When the assay procedure is competed ,dispose the test kit and tube
carefully after autoclaving them at 121°C for at least 30\0mintues. Or treated them with 5% sodium hypochloride for 40-60 minutes, or burn them.

LITERATURE REFERENCES

Beggs M,Novotny M, Sampedro S,et al.A self-performing Chromatographic immunoassay for the qualitative determination of human chorionic gonadotrophic(HCG) in urine and serum ClinChem ,1990,36:1084
Valkirs G.E,Barton R, immunoconcentration A new format for solid-phase immunoassay Clinchem .,1985 31:1427
Knapp,J.S et al. Neisseria gonorrhoeae, Manual of Clinical Microbiology, Sixth Edition, ASM press, Washington DC.,324-325(1995)
Centers for Disease Control and Prevention, Sexually Transmitted Diseases Treatment Guidelines 2002 Morbidity and Mortality Weekly Report(2002),51(rr-6)

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Rebecca Yan

Product Manager
Span Biotech Ltd.
Tel: +86(755)89589611
Cell Phone:+8618823462100(WhatsApp)