syphilis rapid test strip rapid test kits OEM ODM factory

syphilis rapid test strip rapid test kits OEM ODM factory

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Our medical manufacturing companies  are  scientific and technological anti syphilis rapid test factory, which designs, manufactures and sales of In-vitro-Medical diagnosis devices.

syphilis rapid test kits OEM ODM factory OEM ODM factory
syphilis rapid test kit

syphilis-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

syphilis rapid test strip

FunctionFor the qualitative detection of antibodies (IgG, IgM and IgA) to Treponema Pallidum (TP) in human whole blood,serum or plasma.
Formats cassette
Specifications cassette(3mm, 4mm)

or according to the customers’ requirements

Specimens whole Blood/Serum/Plasma
Accuracy over 99.6%
Reaction Time15 minutes
Shelf Life 24 months at room temperature 2- 30 degrees
Packing Details  Cassette

40pcs/bag, 50bags/carton.  500,000pcs/20’ft container

40pcs/box, 50boxes/carton, 550,000pcs/20’ft container

1pcs/box, 500boxes/carton, 120,000pcs/20’ft container
Strip

100pcs/bag, 100bags/carton .1,300,000pcs/20’ft container

100pcs/box, 50boxes/carton, 1,700,000pcs/20’ft container

50pcs/box, 100boxes/carton, 1,600,000pcs/20’ft container

1pcs/box, 500boxes/carton, 120,000pcs/20’ft container

Others The kits can be made according to the customers’ artwork or design

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.