Chlamydia Trachomatis & Neisseria Gonorrhoeae (CT/NG)

Molecular Biology - Infectious Diseases

Chlamydia trachomatis (CT) is the second most leading cause of sexually transmitted diseases worldwide, with approximately 89.1 million cases occurring annually worldwide. CT is the causative infectious agent for a variety of diseases in men, including urethritis, proctitis, conjunctivitis and epididymitis. In women, the consequences of infection with CT are severe if left untreated. Infection can lead to endometriosis, salpingitis (with subsequent infertility and ectopic pregnancy) and perihepatitis. Additionally, infants from infected mothers can develop conjunctivitis, pharyngitis, and pneumonia.

Neisseria gonorrhoeae (NG) is the causative agent of gonorrhoeae. Acute urethritis is seen in the majority of men with gonorrhoeae, and acute epididymitis is the most common complication, particularly in young men. In women, the primary site of infection is the endocervix, there’s a high prevalence of coinfections with CT, Trichomonas vaginalis, and bacterial vaginosis. Many women remain asymptomatic; when symptoms do occur, the most common are increased discharge, dysuria, and intermenstrual bleeding. Additionally, NG may cause pelvic inflammatory disease, endometriosis, tubo ovarian abscess, and pelvic peritonitis.

Preparation of patient: Prior to the collection of urine, the patient should not have urinated for at least one hour. For best results, female patients should not cleanse the labial area prior to collection.

There is no physical preparation for the vaginal swab.

Precautions: None for patient. Media contains Guanidine Thiocyanate, adequate PPE for the person taking the sample.

Note: Chlamydia trachomatis and Neisseria Gonorrhoeae are notifiable diseases under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

Sample Type:

Urine or urine in cobas PCR Urine Media (cobas® PCR Urine Sample Kit).

Endocervical or Vaginal swabs in cobas PCR Media (cobas® Media Dual Swab Kit).

Turnaround Time:

4 working days from sample receipt

Sample Stability:

Urine specimens should be transferred into the cobas PCR media tube as soon as possible. If specimens cannot be transferred immediately, they can be stored at 2-30℃ for up to 24 hours. Stabilised urine specimens are stable at 2-30℃ for up to 12 months.

Swabs collected with the cobas PCR Media Swab Kit may be stored at 2-30℃ for up to 12 months.

Instrument / Procedure:

The cobas® 4800 CT/NG Test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in patient specimens. The test allows for detection of CT/NG DNA in endocervical and vaginal swab specimens, and male and female urine in cobas® PCR Media. The intended targets for the cobas® 4800 CT/NG Test include all fifteen major Chlamydia trachomatis serovars, the Swedish C. trachomatis mutant (nvCT), and both wild-type and variant DR-9 sequences of N. gonorrhoeae.

Units:
Reference Range:

CT and/or NG Detected

Not Detected

Invalid

Precautions:
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Source:
Accreditation Status:
Accredited
Non-Accredited

SAMPLE REQUIREMENTS FOR COAGULATION TESTS

PROCEDURE

Sample Requirements and Collection

  • Patients should be relaxed pre-venepuncture. Excessive stress and exercise will increase FVIII, vWF antigen and fibrinolysis. Venous occlusion should be avoided.  
  • Difficult venepuncture with trauma may lead to platelet activation with release of PF4 from alpha granules.
  • Venous blood should be collected into coagulation tubes containing Sodium Citrate 3.2%, 0.105M.
  • Specimens must be mixed immediately post venepuncture to avoid clot activation, by GENTLY inverting the tubes 5 to 10 times.
  • The ratio of whole blood to anticoagulant is crucial to clotting times. A target blood to anticoagulant ratio of 9:1 is optimal.  Under- or over- filled specimens will not be processed this can adversely affect results.  
  • Any warfarin treatment should be mentioned on the request form.
  • Sample rejection Criteria: Clotted sample, grossly hemolyzed sample, underfilled/overfilled specimen, unlabeled sample, mismatched patient ID, aged samples, wrong sample tube (citrate tube only).

Transportation and Storage

  • PT/INR specimens should be transported to the laboratory at room temperature.
  • Coagulation specimens should ideally be analysed within 4 hours of collection. Where this is not possible, centrifuge specimens at room temperature (RT) @ 1500RCF for at least 15 minutes, and then carefully remove the plasma from the cells, transfer to a fresh plastic plain tube and freeze at -20oC.  
  • Non-frozen coagulation specimens should be transported at RT ASAP to avoid deterioration of labile factors V and VIII.
  • Collection of blood through intravenous lines that have been previously flushed with heparin should be avoided. In the event blood is drawn from an indwelling catheter, the line should be flushed with 5ml of saline, and the first 5ml of blood or 6 times the line volume be drawn off and discarded before coagulation tube is filled.
  • Effect of freezing on Coagulation Specimens.
  • A 14days in-house study on the effect of freezing, on coagulation specimens at -20oC, showed that there was negligible and clinically non-significant effect of freezing on coagulation specimen results. Therefore frozen citrated coagulation samples are stable for 14 days at -20oC, post centrifugation. This study is available in-house for reference.
ESR Ref Ranges
Units of Measurement
MALE
FEMALE
>50 Years
mm/hr
0 - ≤12
0 - ≤15
<50 Years
mm/hr
0 - ≤8
0 - ≤10
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Analyte
Units of Measurement
MALE
FEMALE
WBC
10^9/L
4.0–10.0
4.0 - 10.0
RBC
10^12/L
5.0 ± 0.5
4.3 ± 0.5
HB
g/dL
15.0 ± 2.0
13.5 ± 1.5
HCT
L/L
0.45 ± 0.05
0.41 ± 0.05
MCV
fL
92 ± 9
92 ± 9
MCH
pg
29.5 ± 2.5
29.5 ± 2.5
MCHC
g/dL
33.0 ± 1.5
33.0 ± 1.5
PLT
10^9/L
280 ± 130
280 ± 130
MPV
fL
N/A
N/A
RDW
%
11.6 - 14.0
11.6 - 14.0
#Neut
10^9/L
2.0 – 7.0
(40 - 80%)
#Lymph
10^9/L
1.0 – 3.0
(20 - 40%)
#Mono
10^9/L
0.2 – 1.0
(2 - 10%)
#Eos
10^9/L
0.02 – 0.5
(1 - 6%)
#Baso
10^9/L
0.02 – 0.1
(<1 - 2%)
Analyte
Units of Measurement
MALE & FEMALE
WBC
10^9/L
Birth: 18 ± 8
Day 3: 15 ± 8
Day 7: 14 ± 8
Day 14: 14 ± 8
1 Month: 12 ± 7
2 Months: 10 ± 5
3–6 Months: 12 ± 6
1 Year: 11 ± 5
2–6 Years: 10 ± 5
6–12 Years: 9 ± 4
RBC
10^12/L
Birth: 6.0 ± 1.0
Day 3: 5.3 ± 1.3
Day 7: 5.1 ± 1.2
Day 14: 4.9 ± 1.3
1 Month: 4.2 ± 1.2
2 Months: 3.7 ± 0.6
3–6 Months: 4.7 ± 0.6
1 Year: 4.5 ± 0.6
2–6 Years: 4.6 ± 0.6
6–12 Years: 4.6 ± 0.6
HB
g/dL
Birth: 18.0 ± 4.0
Day 3: 18.0 ± 3.0
Day 7: 17.5 ± 4.0
Day 14: 16.5 ± 4.0
1 Month: 14.0 ± 2.5
2 Months: 11.2± 1.8
3–6 Months: 12.6 ± 1.5
1 Year: 12.6 ± 1.5
2–6 Years: 12.5 ± 1.5
6–12 Years: 13.5 ± 2.0
HCT
L/L
Birth: 0.60 ± 0.15
Day 3: 0.56 ± 0.11
Day 7: 0.54 ± 0.12
Day 14: 0.51 ± 0.12
1 Month: 0.43 ± 0.10
2 Months: 0.35 ± 0.07
3–6 Months: 0.35 ± 0.08
1 Year: 0.34 ± 0.04
2–6 Years: 0.37 ± 0.03
6–12 Years: 0.40 ± 0.05
MCV
fL
Birth: 110 ± 10
Day 3: 105 ± 13
Day 7: 107 ± 19
Day 14: 105 ± 19
1 Month: 104 ± 12
2 Months: 95 ± 8
3–6 Months: 76 ± 8
1 Year: 78 ± 6
2–6 Years: 81 ± 6
6–12 Years: 86 ± 9
MCH
pg
Birth: 34 ± 3
Day 3: 34 ± 3
Day 7: 34 ± 3
Day 14: 34 ± 3
1 Month: 33 ± 3
2 Months: 30 ± 3
3–6 Months: 27 ± 3
1 Year: 27 ± 2
2–6 Years: 27 ± 3
6–12 Years: 29 ± 4
MCHC
g/dL
Birth: 33.0 ± 3.0
Day 3: 33.0 ± 4.0
Day 7: 33.0 ± 5.0
Day 14: 33.0 ± 5.0
1 Month: 33.0 ± 4.0
2 Months: 32.0 ± 3.5
3–6 Months: 33.0 ± 3.0
1 Year: 34.0 ± 2.0
2–6 Years: 34.0 ± 3.0
6–12 Years: 34.0 ± 3.0
PLT
10^9/L
Birth: 100 – 450
Day 3: 210 – 500
Day 7: 160 – 500
Day 14: 170 – 500
1 Month: 200 – 500
2 Months: 210 – 650
3–6 Months: 200 – 550
1 Year: 200 – 550
2–6 Years: 200 – 490
6–12 Years: 170 – 450
Reticulocytes
10^9/L
Birth: 120 – 400
Day 3: 50 – 350
Day 7: 50 – 100
Day 14: 50 - 100
1 Month: 20 – 60
2 Months: 30 – 50
3–6 Months: 40 – 100
1 Year: 30 – 100
2–6 Years: 30 – 100
6–12 Years: 30 – 100
#Neut
10^9/L
Birth: 4 – 14
Day 3: 3 – 5
Day 7: 3 – 6
Day 14: 3 – 7
1 Month: 3 – 9
2 Months: 1.0 – 5
3–6 Months: 1 – 6
1 Year: 1 – 7
2–6 Years: 1.5 – 8
6–12 Years: 2 – 8
#Lymph
10^9/L
Birth: 3 – 8
Day 3: 2 – 8
Day 7: 3 – 9
Day 14: 3 – 9
1 Month: 3 – 16
2 Months: 4 – 10
3–6 Months: 4 – 12
1 Year: 3.5 – 11
2–6 Years: 6 - 9
6–12 Years: 1 - 5
#Mono
10^9/L
Birth: 0.5 – 2.0
Day 3: 0.5 – 1.0
Day 7: 0.1 – 1.7
Day 14: 0.1 – 1.7
1 Month: 0.3 – 1.0
2 Months: 0.4 – 1.2
3–6 Months: 0.2 – 1.2
1 Year: 0.2 – 1.0
2–6 Years: 0.2 – 1.0
6–12 Years: 0.2 – 1.0
#Eos
10^9/L
Birth: 0.1 – 1.0
Day 3: 0.1 – 2.0
Day 7: 0.1 – 0.8
Day 14: 0.1 – 0.9
1 Month: 0.2 – 1.0
2 Months: 0.1 – 1.0
3–6 Months: 0.1 – 1.0
1 Year: 0.1 – 1.0
2–6 Years: 0.1 – 1.0
6–12 Years: 0.1 – 1.0
Reference Ranges:
Age
Absolute Reference Range
Age
% Reference Range
0 - 1 day
324 - 617 x109/L
0 - 1 day
1.72 - 8.62%
1 - 5 days
85 - 400 x109/L
1 - 5 days
1.9 - 9.1%
5 days - 1 mth
34.2 - 724 x109/L
5 days - 1 mth
0.1 - 6.9%
1 - 3 mths
21.3 - 205 x109/L
1 - 3 mths
0.1 - 6.27%
3 - 12 mths
8.0 - 171 x109/L
3 - 12 mths
0.1 - 4.7%
1 - 3 yrs
55.6 - 120 x109/L
1 - 3 yrs
0.35 - 2.95%
3 - 7yrs
16.4 - 120.7 x109/L
3 - 7yrs
0.25 - 2.57%
Adult
35.2 - 122.8 x109/L
Adult
0.75 - 2.7%
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