Instructions for use of special staining solution for epithelial tissue

【Product name】 Special staining solution for epithelial tissue

【Product composition】Acetic acid, phosphotungstic acid, sodium chloride, pure water, etc.

【Product specification】 2ml/piece, 1 piece/box.

【 Storage conditions 】 Sealed, away from light, below 40℃, cool and dry place.

【Intended use】For special staining before histopathological analysis of exfoliated cervix.

【 Product Features 】

1. Fast and accurate: the result is produced within 5 minutes, and the color interpretation is intuitive; High sensitivity and specificity.

2. Simple and safe: naked eye observation, no equipment requirements; It does not hurt cervical tissue, the patient has no pain and adverse reactions, the compliance is high, and the patient is easy to accept.

3. Objective interpretation: to help doctors make early clinical decisions and improve the conformity rate of clinical diagnosis.

4. Supplement and improve: It does not conflict with or replace the existing examination methods, improve the detection rate of cytology and colposcopy, and reduce the rate of missed diagnosis.

【 Detection principle 】

Special histocytological staining for shedding cells, especially for cervix, vagina, vulva and other clinical routine examination. The variation of shed histocytes in urine produces characteristic color reaction with the staining solution, and the change of color of the color reaction product is related to the amount of mutated histocytes in urine.

【 Scope of application 】

Health screening for women. According to the principle of cell metabolism, the screening method of ultra-early and other stages of cervical cancer can realize the whole process monitoring of cervical cancer. To provide a new means of cervical pain screening, so as to significantly reduce the incidence and mortality of cervical cancer.

【 Sample Collection and Requirements 】

1. Fresh clean urine sample.

2. Avoid sex for 24 hours before sampling and eat normally.

3. Avoid drinking large amounts of water 4 hours before sampling.

【 Usage method 】

1. Take fresh clean urine sample and add 1ml urine into ampoules with a  dropper.

2. Shake to mix the liquid evenly and let it sit for 5 minutes to observe the result.

3. Compare with color cards.

【 Criteria 】

Negative: colorless or light yellow.

Weak positive: light blue or grayish blue.

Positive: blue-green or blue.

Strong positive: dark blue.

【 Note 】

1. This product is only used for in vitro diagnosis.

2. If the solution turns green or blue before use, do not use it.

3. Menstrual period prohibited.

4. Observe the results within five minutes.

5. Use with caution in diabetic patients.

【Production record Certificate Number】 E Han Food and Drug Administration equipment production preparation  No. 20230016

【Medical device product filing certificate number】E Han Instrument No. 20180029

【 Manufacturer 】 Ja Na Biotechnology (Wuhan) Co., LTD

【Case preparer】 Ja Na Biotechnology (Wuhan) Co., LTD

【Production address】 Area A A0402, R & D Building, No.666 Shendun Fourth Road, East Lake New Technology Development Zone, Wuhan City

【Record address】 Area A0402, R & D Building, No.666 Shendun Fourth Road, East Lake New Technology Development Zone, Wuhan

【Production date】 See packing box.

【 Effective period 】 Two years

【 Specification Approval and amendment Date 】2023/2/3

【 Postal Code 】430070