anti syphilis rapid test strip rapid test kits OEM ODM factory OEM ODM factory

anti syphilis rapid test strip rapid test kits OEM ODM factory OEM ODM factory
Our mission is to produce and sell the highest quality rapid tests for humans.

Syphilis Ab Rapid Test (Whole Blood/Serum/Plasma) is a rapid, serological, immunochromatographic assay for the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema Pallidum (TP) in human whole blood,serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with TP . Any reactive specimen with the Syphilis Ab Rapid Test Strip must be confirmed with alternative testing method(s) and clinical findings.

PRODUCT DESCRIPTION

anti syphilis rapid test strip rapid test kits OEM ODM factory

anti syphilis rapid test strip rapid test kits OEM ODM factory

MATERIALS

MATERIALS SUPPLIED

1. Test devices 2.Pipette Dropper 3.Desiccant 4.Buffer 5.Package Insert
   MATERIAL REQUIRED BUT NOT PROVIDED
2. Specimen collection containers.
3. Lancets (for fingerstick whole blood only)
4. Centrifuge (for plasma only)
5. Timer
6. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

STORAGE AND STABILITY

All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.

WARNINGS AND PRECAUTIONS

1. For professional in vitro diagnostic use only. Do not use after expiration date.
2. Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to prevent azide build-up.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results .
8. Do not perform the test in a room with strong air flow, ie. an electric fan or strong airconditioning.

SPECIMEN COLLECTION

1. Syphilis Ab Rapid Test (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
2. To collect Fingerstick Whole Blood specimens:
   Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
   Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
   Puncture the skin with a new sterile lancet for each person. Wipe away the first sign of blood.
   Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
   Add the Fingerstick Whole Blood specimen to the test device by using a capillary tube:
   Touch the end of the capillary tube to the blood until filled to approximately 50 μL. Avoid air bubbles. Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole blood into the sample pad of the test strip.
   Add the Fingerstick Whole Blood specimen to the test strip by using hanging drops:
   Position the patient’s finger so that the drop of blood is just above the sample pad of the test strip. Allow 2 hanging drops of fingerstick whole blood to fall into the center of sample pad of the test strip, or move the patient’s finger so that the hanging drop touches the center of the sample pad of the test strip. Avoid touching the finger directly to the sample pad.
3. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
4. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
6. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

TEST PROCEDURE

Allow test, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test strip from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test strip on a clean and level surface.
   For Serum or Plasma Specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 60 μL) to the sample pad of the test strip. See illustration below.
   For Venipuncture Whole Blood Specimens: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50μL) to the sample pad of the test strip, then add 1 drop of buffer (approximately 30 μL) and start the timer. See illustration below.
   For Fingerstick Whole Blood Specimens: Allow 2 hanging drops of fingerstick whole blood (approximately 50 μL) to fall into the center of the sample pad of the test strip, then add 1 drop of buffer (approximately 30 μL) and start the timer. See illustration below.
3. Wait for the red line(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 15 minutes.

PRODUCT INSTRUCTION DISPLAY

anti syphilis rapid test strip rapid test kits OEM ODM factory

OUR FACTORY AND WORKSHOP

China Tianjin Recare Co., Ltd. is a pioneer in the rapid test manufacturing industry and distribution in China,has been in this line more than 15 years. We owned more than 100 workers, the capacity is more than 1 million pieces of test per month. Our rapid test has been sold in more than 160 countries and places. Rapid tests supplied by Recare are highly regarded for high accuracy and reliability in the commercial markets and non-commercial markets.We are also the supplier of UN.

OUR ADVANTAGES

1. Best service: quality control, convenient custom clearance, door to door shipping service
2. Faster email response on every inquiry and high quality competitive price
3. Small quantity orders are acceptable
4. Rich experience to work with famous company and brands
5. OEM packaging : custom foil pouch,custom small box,custom medium box,custom carton
6. Supply free samples
7. Timely sample and mass production delivery date

PRODUCTION PROCESS

OUR CERTIFICATES

OUR EXHIBITIONS