A rapid test for the qualitative detection of IgM antibody to Chlamydia Trachomatis in
human whole blood, serum or plasma.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Chlamydia IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay
for the qualitative detection of IgM antibody to Chlamydia Trachomatis in human whole
blood, serum or plasma to aid in the diagnosis of Chlamydia Trachomatis infection.
【SUMMARY】
Chlamydia Trachomatis are round cells between 0.3 and 1 µm in diameter depending on
the stage in the replicative cycle. Their envelope is of the gram-negative type including
an outer membrane that contains lipopolysaccharide and proteins. The outer membrane
includes a major outer membrane protein (MOMP) which is immunogenic.1
Chlamydia trachomatis causes disease in several sites, primarily the conjunctiva and
genital tract. In its various forms, this infection is one of the most frequent in the world
with an estimated 100 million new cases each year. Humans are the sole reservoir.
Inclusion conjunctivitis is seen among population groups in which the strains causing
C.trachomatis genital infections are common.1
Chlamydial infection is the most frequently reported bacterial infectious disease in the
United States, and prevalence is highest among persons aged ≤24 years. Multiple
sequelae can result from C. trachomatis infection among women, the most serious of
which include PID, ectopic pregnancy, and infertility. CDC recommends annual screening
for all sexually active women < 25 years of age.2
【PRINCIPLE】
The Chlamydia IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative,
lateral flow immunoassay for the detection of IgM antibody to Chlamydia Trachomatis in
whole blood, serum or plasma specimens. In this test, Chlamydia Trachomatis
recombinant protein are coated in the test line regions of the test. During testing, the IgM
to Chlamydia Trachomatis in whole blood, serum or plasma specimen reacts with mouse
anti-human IgM coated particles in the test strip, then the antibody-antigen complex will
be captured with Chlamydia Trachomatis recombinant protein in the membrane when
migration. The presence of a colored line in the test line region indicates a positive result
for Chlamydia infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the control line
region of the strip indicating that proper volume of specimen has been added and
membrane wicking has occurred.
【REAGENTS】
The test contains Chlamydia Trachomatis recombinant protein as the capture reagent,
and mouse anti-human IgM as the detection reagent. A goat anti-mouse IgG and mouse
IgG are employed in the control line system.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. Do not smoke, drink, or eat in areas where specimens or kits reagents are handled.
3. Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are being tested.
4. Humidity and temperature may adversely affect results.
5. The used test should be discarded according to local regulations.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The
test is stable through the expiration date printed on the sealed pouch. The test must
remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the
expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
The Chlamydia IgM Rapid Test Cassette can be performed using whole blood, serum or
plasma.
1. To Collect Fingerstick Whole Blood:
Wash the patient’s hand with soap and warm water or clean with an alcohol pad.
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 sterile lancet. 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.
2. To Collect Venipuncture Whole Blood:
Collect venipuncture whole blood specimen into a collection tube containing EDTA-K2,
sodium citrate, heparin sodium and potassium oxalate. Do not use hemolyzed blood for
testing. Mix whole blood by inversion and use in the test as outlined in the Test
Procedure.
3. To collect Plasma/Serum:
Step 1:
Collect venipuncture blood specimen into collection tube containing EDTA-K2, sodium
citrate, heparin sodium and potassium oxalate for plasma or collection tube without
anticoagulants for serum.
Step 2:
To prepare plasma specimen, centrifuge collected specimens and carefully transfer the
plasma into a new pre-labeled tube.
To prepare serum specimen, allow blood to clot, centrifuge collected specimens and
carefully transfer the serum into a new pre-labeled tube.
4. Testing should be performed immediately after the specimens have been collected. Do
not leave the specimens at room temperature for prolonged periods. Serum and
plasma specimens can be stored at 2-8°C for up to 3 days and -20°C for 12 months.
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. It is recommended not to freeze and
thaw more than 3 times in both serum and plasma specimens.
6. If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials provided
Test cassettes
Package insert
Buffer
Droppers
Materials required but not provided
Specimen collection containers
Centrifuge
Lancets (for fingerstick whole blood only)
Pipette
Alcohol pad
Timer
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-
30°C) prior to testing.
1. Remove the test from the foil pouch and use it within one hour. Best results will be
obtained if the test is performed immediately after opening the foil pouch.
2. Place the test on a clean and level surface.
For Serum or Plasma specimen:
Use a dropper: Hold the dropper vertically and transfer 1 full drop of serum or
plasma (approximately 10μL) to the specimen well(S), then add 2 drops of buffer
(approximately 80µL) to the buffer well(B), and start the timer.
Use a pipette: To transfer 10µL of serum or plasma to the specimen well(S), then
add 2 drops of buffer (approximately 80µL) to the buffer well(B), and start the timer.
For Whole Blood (Venipuncture/Fingerstick):
Use a dropper: Hold the dropper vertically, transfer 2 full drops of whole blood
(approximately 20μL) to the specimen well(S), then add 2 drops of buffer
(approximately 80µL) to the buffer well(B), and start the timer.
Use a pipette: To transfer 20µL of whole blood to the specimen well(S), then add 2
drops of buffer (approximately 80µL) to the buffer well(B), and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret
the result after 20 minutes.
Note: it is suggested not to use the buffer beyond 6 month after opening the vial.
