Report Suspicious Activity
Overview
Quick Details
Type:
Pathological Analysis Equipments
Brand Name:
EGENS
Place of Origin:
Jiangsu, China (Mainland)
Certificate:
ISO9001,ISO13485
Storage:
2-30℃
Shelf Time:
2 years
Packaging & Delivery
Packaging Details
96T/48T per box
Port
Shanghai port

Specifications

rapid test kits
1.easy to use
2.easy to read
3.High accuracy
4.High speed

INSTRUCTIONS FOR USE
Anti-TP ELISA
For the detection of antibodies to Treponema Pallidum
in human serum or plasma (in vitro)

INTENDED USE
The Anti-TP ELISA is a qualitative enzyme immunoassay for the in vitro detection of Treponema Pallidum infection,
based on the detection of antibodies to Treponema Pallidum in human serum or plasma. It is intended for
screening of blood donors and diagnosing patients related to infection with Treponema Pallidum.
COMPONENTS
1. Microplate 96 wells
2. Negative Control 1 mL ×1
3. Positive Control 1 mL ×1
4. Sample Diluent 6 mL ×1
5. Conjugate 12 mL ×1
6. Washing Buffer (20×) 40 mL ×1
7. Substrate Solution A 6 mL ×1
8. Substrate Solution B 6 mL ×1
9. Stop Solution 6 mL ×1
10. Plate Cover 3 pieces
11. Insert 1 copy

 

ASSAY PROCEDURE
1. Prepare Reagents: Dilute 1 volume of Concentrated Washing Buffer (20×)with 19 volumes of distilled water,
mix well.
2. Add Samples: Open the foil pouch and remove the Microplate. Set up 1 well as Blank, 2 wells as negative
control, 2 wells as positive control. After dispensing 50µL of Sample Diluent , dispense 50µL of sample or
negative control or positive control to the respective wells. Gently vibrating the plate.
3. Incubate: Cover the Microplate with plate cover and incubate the Coated Microplate in a thermostat-controlled
water-bath or microplate incubator at 37℃ for 60 minutes.
4. Wash the Plate: Remove the plate cover. Aspirate the contents of all wells. Fill the wells with the diluted
washing buffer ( 10~20 seconds to soak) then aspirate again. Repeat the procedure for 5 times. Make sure
that the rest volume is minimal, by tapping plate onto absorbent paper.
5. Add Conjugate: Add 100µL of conjugate to each well (except the blank well).
6. Incubate: Cover the Microplate and incubate the plate at 37℃ for 30 minutes.
7. Wash the Plate: Repeat the wash procedure as in step 4.
8. Add Substrate: Add 50µL of Substrate Solution A and 50µL of Substrate Solution B to each well, mix well.
Cover and incubate at 37℃ for 10 minutes.
9. Stop reaction: Add 50µL Stop Solution to each well, mix well.
10. Read the absorbance at 450 nm. If a dual wavelength measurement is used, the reference wavelength should
be selected from 620nm to 690nm.
RESULTS
1. For the assay to be valid, the mean OD value of negative controls must be less than or equal to 0.1 and the
mean OD value of positive controls must be greater than or equal to 0.8.
2. Cut off value = 0.1+NC
NC= the mean absorbance value for two negative controls
Important: If the NC is lower than 0.05, take it as 0.05.
3. OD value of the sample ≥ cut off value, it is positive for anti-TP.
OD value of the sample < cut off value, it is negative for anti-TP.
PRECAUTIONS
1. Allow all kit components to reach room temperature before use.
2. Follow the direction insert to control the reaction temperature and time strictly.
3. Do not mix components of different lot numbers to use.
4. The kit should be store at 2-8℃. Do not use kit components beyond their expiration date