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POCT
Date of issue 02/11/2011
Clinitest hCG pregnancy test on the CLINITEK STATUS
analyser
This SOP has been compiled by the POCT committee to provide a template
compatible with Clinical Pathology Accreditation standards, containing information
users need to achieve consistently reliable and accurate results. This SOP should
be read in conjunction with the manufacturer’s manual and strip insert.
Clinical Relevance/ purpose of examination
Human chorionic gonadotropin (hCG) is a hormone produced by the placenta shortly
after implantation. Recent studies suggest that urine hCG concentrations are
approximately one-half of, or less than one-half of corresponding serum
concentrations. Thus, hCG can likely be detected in urine as early as 14 days after
conception (approximately 28 days since the last menstrual cycle), doubling in
concentration about every two days until it peaks at approximately 8-10 weeks after
the last menstrual period. The appearance of hCG soon after conception and its
subsequent rise in concentration during early gestational growth makes it an
excellent marker for the early detection of pregnancy.
POCT pregnancy testing is clinically indicated in: • Suspected pregnancy
• Pre-surgical procedures
• Pre-X-ray and Radioisotope procedures
The Clinitest Kit is for in vitro diagnostic use in the rapid detection of human chorionic
gonadotropin (hCG) in urine specimens. This test kit is used to obtain a Clinitek
Status® analyser, semi-quantitative, result and is intended for near-patient (point-ofcare) and centralised laboratory locations.
Principle of examination
Clinitek Status
The Clinitek Status® analyser is a portable instrument for reading Bayer urinalysis
strips and Clinitest immunoassay cassettes based on reflectance spectrometry.
Touching the Cassette Test or Strip Test key prompts you to adjust the test table to
accept a urinalysis strip or cassette. After touching the START key you have 8
seconds apply the sample to the strip or cassette. After 8 sec the table is partially
pulled into the instrument for calibration and then pulled completely into the
instrument to read the test strip or cassette.
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POCT
Date of issue 02/11/2011
CLINITEST hCG Test Kit
The Clinitest hCG Pregnancy Test is a chromatographic immunoassay (CIA) for the
rapid determination of hCG in urine. The membrane is precoated with anti hCG
capture antibody on the test line region (T) and goat anti-mouse IgG on the control
line region (C). During testing, the urine specimen is allowed to react with colloidal
gold particles coated with anti-beta hCG monoclonal antibody. The mixture then
chromatographically moves along the membrane by capillary action. For a positive or
borderline result, a pink-coloured line with a specific antibody-hCG-antibody-colloidal
gold particle complex will form on the membrane in the test line region. A pinkcoloured line at the reference region (R), the area between the control line region and
the test line region) has been adjusted to a level approximating 25 mlU/mL hCG.
Absence of a pink-coloured line in the test line region indicates a negative result. The
appearance of a coloured line in the control region and the reference region serves
as verification that sufficient volume has been added and that proper flow has
occurred.
Specimen requirements and means of identification
Universal Precautions must be followed when handling body fluids.
Urine is the recommended sample type for this assay.
• Collect urine into a clean, dry container labelled with minimum identifiers (i.e. Full
name and DOB or hospital number).
• Specimens collected at any time of day may be used; however, the first morning
urine generally contains the highest concentration of hormone.
• Refrigerate specimens at 2° to 8°C (36° to 46°F) for up to 72 hours, if the testing is
not performed immediately.
• If samples are refrigerated, bring them to room temperature before testing.
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POCT
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NOTE: Urine specimens should be stored in the smallest possible plastic container.
Large containers (especially glass) are to be avoided because hCG sticks to the
surface of containers. Urine samples exhibiting visible precipitates should be allowed
to settle prior to testing or sent to the lab for centrifugation and testing.
Sample Rejection Criteria
If sample is heavily blood stained the test should not be performed. Blood should be
drawn and sent to the biochemistry laboratory.
Where it is not feasible due to the urgent nature of the request, to send blood to the
lab, a blood stained urine sample should be allowed to settle and a particulate free
aliquot analysed. The result should be treated with caution and interpreted in
conjunction with the clinical presentation. Where doubts persist as to the validity of
the result obtained then any planned procedure must be delayed until the result is
confirmed by the laboratory on a blood sample.
Where a urine sample appears very dilute (i.e. very little colour) it may not contain
measurable levels of hCG and the specific gravity should be checked with a
urinalysis dipstick. If the specific gravity is 1.005 or less the test should not be
performed.
A repeat sample, preferably first morning urine, should be obtained.
If the result is required urgently blood should be drawn and sent to the biochemistry
laboratory.
When an hCG result is required urgently and a urine sample cannot be used
biochemistry should be contacted to inform that the request is urgent and the
request form should be marked “urgent”.
Equipment
Clinitek Status analyser
Urine specimen collection containers
Disposable gloves
Reagent, standards or calibrators and IQC material
Clinitest pregnancy kit
Clinitest kit [distributed by Pharmacy] contains everything needed to perform hCG
pregnancy tests:
- Clinitest cassette
- Disposable plastic pipette
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POCT
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- Instruction leaflet
The test kit can be stored either refrigerated or at room temperature, 2°-30°C (36°86°F), for the duration of the shelf-life. Do not use the test beyond the expiration
date. If refrigerated, bring the wrapped cassettes to room temperature before
opening the protective pouch to avoid moisture condensation on the membrane.
IQC Material
Any unit that requires IQC material for equipment, staff competency or training
checks should contact the POCT team (CAH Ext. 2660)
Calibration
The Clinitek Status® will perform an automatic calibration each time a test is run.
Instructions for the performance of the examination
Please familiarise yourself with the kit insert and Clinitek Status operating manual
which are available on the laboratory web-site before conducting test outlined in this
procedure.
Do not use cassettes beyond the expiration date which appears on the package
label. Do not use a test from a damaged protective wrapper.
Switch on the analyser (if not already on) using the gray button.
Testing is started from the main Select screen.
Touch Cassette Test to conduct the Clinitest hCG test.
Bring the test cassette and patient sample to room
temperature (20°C to 30°C) prior to testing.
The next screen that appears is Operator ID. In order to
enter the information for a new operator, touch Enter New Operator ID button. The
next screen that is displayed is Enter Operator ID.
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POCT
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Use the keyboards to enter Operator ID (full name or last 5 digits of staff number)
using a maximum of 13 characters. To change from keyboard to numerical or vice
versa touch the 123 or ACB button.
Touch Enter when you have finished entering the ID to move to the next screen.
Operator ID MUST appear on every test.
The next screen displayed is Patient Information.
There are two options under Patient Information: Recall Patient or Enter New
Patient.
Option 1: Recall Patient
In order to look up previous patients, touch Recall Patient.
If the previous patient identification has been entered, a list of up to 200 patients will
appear on the screen. Use the up and down arrow buttons to scroll through the list of
patients. The most recently performed test will be shown at the top.Once the patient
is high-lighted touch the Select button. The next screen will be Test Type.
Option 2: Enter New Patient
In order to enter the information for a new
patient, touch the Enter New Patient button.
The next screen displayed is Enter Patient
Name. Use the keyboards to enter Patient
Name using a maximum of 20 characters.
Touch Enter when you have finished entering
the patient’s name to move to the next screen.
The next screen displayed is Enter Patient ID. Use the keyboards to enter Patient
H&C number using a maximum of 13 characters. Touch Enter when you have
finished entering the patient’s ID and are ready to proceed to the next screen.
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POCT
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The next screen that appears is Test Type. Touch the Clinitest hCG cassette button.
The next screen that appears is Prepare Test screen.
Make sure the test table insert is in position for a cassette test.
Remove the test cassette from the foil package and place the
cassette on the test table. Do not use opened pouches, as kit is
moisture sensitive.
Using the dropper provided and holding it at a slight
angle, squeeze the upper square bulb and place into
the sample. Draw up enough sample to fill the
straight stem completely without air bubbles. Any
excess will go into the lower reservoir bulb.
Touch START button.
The next screen that appears is another Prepare
Test. This screen prompts you through the steps to
prepare the cassette test.
A timer displays how much time you have remaining
to complete the steps.
Place the end of the pipette in the sample well of the
cassette.
Gently SQUEEZE the bulb to fill the sample well with
200uL of urine.
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POCT
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DO NOT add extra urine, or push or pull the test table.
The cassette will be drawn into the analyser. The screen will display the time elapsed
and indicate a test in progress.
Positive results may be available in approx 2 minutes, otherwise the test will take five
minutes. DO NOT INTERFERE ONCE THE TEST IS RUNNING.
When analysis is complete, the results will be printed.
Remove the used cassette and dispose of it in a suitable yellow bag or bin.
Wipe the table with an alcohol wipe.
You may switch the analyser off via the gray button or leave it in standby.
Recording and calculation of results
The analyser has performed its own quality control, and compares the intensity of the
test region (T) with the Control (C) and Reference (R) regions.
Negative:
The concentration is less than the limits of detection of 25mIU/mL hCG
NB Patients who are suspected of being pregnant should be retested in
48-72 hours. If an ectopic is suspected, you may require a blood hCG
for confirmation. Contact the laboratory.
Positive:
The concentration in the sample is above 25mIU/mL hCG
Borderline The result is indeterminate. Repeat in 48-72 hours. If a result is required
urgently then a blood sample should be drawn and sent to the
laboratory for a serum hCG level.
Invalid:
The instrument will detect a procedural error or test reagent
deterioration. This might be due to insufficient sample, heavily
bloodstained sample, poor technique or a faulty cassette. Review the
procedure and repeat the test using a new cassette, ensuring that the
expiry date has not been exceeded. If the problem persists, discontinue
use and report the problem to the POCT team or Cruinn.
Results must be recorded in the POCT log sheet and printouts attached to the
patient notes. If you use Sellotape make sure it is not over any of the printing.
Due to the fact that false positives can occur, any positive result for a child under 16
years should be confirmed by either sending a blood sample for serum hCH to the
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laboratory, by US scan, or both. (See policy for checking pregnancy before surgery,
X-ray diagnostics and chemotherapy)
http://shsctintranet.hpss.ni.nhs.uk/HTML/PandP/documents/PolicyforCheckingpregnancybeforesurgeryxraydiagnostics
andchemotherapy.pdf
The RCPath recommend that near patient results should be entered on patient’s
record. Otherwise, keep at least 30 years. All logs should be retained for lifetime of
instrument or a minimum of 10 years.
Limitations of examination (interference’s, cross reactions
reportable intervals)
The test is not intended to detect conditions other than pregnancy. A number of
conditions other than pregnancy, including trophoblastic disease and certain
nontrophoblastic neoplasms, can cause elevated levels of hCG.
If a urine specimen is too dilute it may not contain measurable levels of hCG. If
pregnancy is still suspected, a first morning urine should be obtained from the patient
48-72 hours later and tested. If urgent then a serum hCG should be sent to the
laboratory.
As with all diagnostic tests, a clinical diagnosis should not be based on the result of a
single test, but should only be made by a physician after all clinical and laboratory
findings have been evaluated.
Patients on antibody therapies may obtain invalid results due to the presence of
interfering antibodies in the medications.
The presence of heterophile antibodies or non-specific protein binding may cause
false-positive results in sensitive immunoassays. If a qualitative interpretation is
inconsistent with the clinical evidence, results should be confirmed by laboratory
serum hCG method.
No known cross reactivity with other homologous hormones for full detail see
manufacturer’s insert.
A large number of compounds were tested for interfering effects. No compound
tested was found to interfere with the assay. A complete list of compounds and
concentrations tested can be found in the manufacturer’s insert.
Methadone, imaging media, catheterisation lubricants and Night Nurse cold remedy
may interfere.
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POCT
Date of issue 02/11/2011
Common causes of positive/borderline results in women who are not pregnant
 Several weeks after delivery, miscarriage or hCG injections
 Passively acquired hCG from blood transfusions
 Menopause
 Interfering substances including catheterisation lubricants
 Trophoblastic disease
Common causes of false negative results
 hCG levels only exceed 25 IU/L 25-27 days after the last period
 Urine contaminated with blood
 Under filling of sample well
 Using a cold cassette or operation in cold environment
 Instrument calibration bars that are soiled
Common operator errors
 Over-filling results in false positives
 Under-filling results in false negatives

Pressing start after adding sample cause incorrect timing of test and the result
may be unreliable
 running cold cassettes, both cassettes and urine must be at room temperature
before testing
Internal Quality Control
Each test includes procedural controls, which indicate that sufficient sample was
added for capillary flow to occur and the correct procedural technique was used. If
these are not detected within 2 minutes after starting the test, an error is reported
and the test must be repeated.
A sample of all new lots of strips will be forwarded by pharmacy to the POCT team
for IQC testing.
IQC record will be retained for at least ten years as per RCPath guidance.
External Quality Control
Three urine based EQA samples are supplied by WEQAS bimonthly. These should
be analysed by a member of staff as per protocol and results returned on the
enclosed return form along with user details before the return by date. The results
should also be recorded on the POCT results log sheet
The results will be transmitted to WEQAS and a summary report will be forwarded to
each unit prior to the next distribution
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POCT
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Please note it is good practise to maximise over the yearly EQA cycle the number of
users involved in EQA sample analysis.
Maintenance
Keep the instrument clean.
Wipe the screen gently with a damp tissue or detergent wipe and dry.
Every 50 tests you will be prompted to clean the table. The table should be cleaned
at least this often and as necessary.
To disinfect 5% sodium hypochlorite (full strength or diluted up to 1:20) or 70-85%
isopropyl alcohol can be used but it is essential that solutions do NOT come into
contact with the white calibration bar.
The test table insert can be removed, cleaned, rinsed under running water and dried.
The whole test table can be cleaned by pulling it slowly out of the analyser and the
lower part cleaned in a similar manner to the insert.
The white calibration strip should not become dirty with normal use but if necessary it
can be gently cleaned with a cloth wetted with distilled water and allowed to air dry.
If the calibration strip is scratched or dirty results will not be reliable.
If it cannot be cleaned a new test table must be obtained.
Reinsert the table by holding at the end opposite the white calibration bar with the
white bar facing upwards. Push the table firmly but slowly, just over halfway into the
analyser. Turn the instrument off using the grey button, and then back on again.
The table will reset itself.
Replacing paper: Ensure that you have the correct thermal printer paper available
from Vector Scientific (See contact details below).
Non sticky backed paper – Ref 8727986
Sticky backed paper – Ref 6352780
To insert paper:
A “paper out” icon may be showing on screen, or the paper shows a red warning line.
Open the printer cover by pulling the grey tab at the top of the printer cover.
Open the paper roll cover by pressing down on the white tab and then pulling it up.
Inside you will see a grey locking arm, lift this up to release the paper.
Remove the old paper roll and place the new roll into the paper compartment with the
paper unrolling from underneath and towards the compartment wall (there is a picture
inside the cover to show you how).
Cut or fold the paper into a point and gently feed the paper along the wall and
through the printer until you have pulled about 4 inches through. Feed the end
though the printer cover. Push the paper-locking arm back into the down position and
close the covers, clicking them into position.
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Check that all is well by selecting a result from the screen and pressing print.
For trouble shooting and non-routine maintenance refer to the operator’s manual
located in the POCT section of the laboratory web site.
Service
Should a fault occur on one of the meters please refer to the instruments manual
(troubleshooting section) or telephone the POCT team on 0283861 2660/3709.
Reporting reference limits
Healthy men and healthy non-pregnant women do not have hCG levels detectable
when using the Clinitest hCG Pregnancy Test. For pregnant women, hCG levels of
100 mIU/mL can be reached on the day of the first missed menstrual period. hCG
levels peak about 8-10 weeks after the last menstrual period and then decline to
lower values for the remainder of the pregnancy. hCG levels rapidly decrease and
usually return to normal within days or up to several weeks after a normal delivery,
delivery by caesarean section, spontaneous abortion, or therapeutic abortion.
Alert critical values
All inconclusive tests should be repeated. See results section.
Local protocol in relation to the reporting of critical results should be adhered to.
Responsibilities of personnel in authorising, reporting and
monitoring reports
Following the death of a patient, attributed to the inadequate use of a glucose meter,
the DOH issued a hazard notice in 1987. This and a more recent notice (1996)
highlights the need for a formal staff training programme for meter use together with
a strict quality control programme. Before performing POCT you should have
attended a relevant training session Meters should only be used with the approval
of the POCT committee. This advice is applicable to all POCT devices
Staff responsibilities are outlined in the Trust POCT policy
All staff working in a healthcare environment have a responsibility to report any
incident involving POCT devices to the ward manager and POCT coordinator.
The manufacturer will provide the following support:
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POCT
Date of issue 02/11/2011



Initial training – Provided by Siemens Northern Ireland Nurse Educator, Anne
Chapman. Tel 0788 763 0739
Audit
Sales and consumables – via Vector Scientific
Vector Scientific contact details:
Address:
Maryland Industrial Estate
286 Ballygowan Road
Monryrea
BT23 6BL
Product Information and Support: Vector Scientific Limited
Contact:
Alan Crooks
Telephone 028 90 448800
Fax:
028 90 449400
Email:
a.crooks@vectorscientific.co.uk
Ordering and sales queries:
Vector Scientific Limited
Contact:
Lorraine Ferguson
Telephone 028 90 448800
Fax:
028 90 449400
Email:
l.ferguson@vectorscientific.co.uk
The laboratory POCT Team (CAH ext 2660) will provide the following support
 Loan instruments
 Advice on POCT QMS
 Schedule training
 Audit
 IQC of new strip lots
Pharmacy will provide the following support
 Supply Cinitest HCG test strips.
 Forward sample of new lot to the POCT team
Hazards and safety precautions
Universal Precautions must be followed when handling body fluids.
Refer to COSHH assessment.
Performance criteria
See Kit insert
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Uncertainty of measurement
Not applicable as qualitative.
Comparability
The following comparison between the Clinitest strips and the laboratory method was
reported as part of the WEQAS pregnancy scheme distribution 54 and 59
Urine HCG
concentration
(IU/L)
0
15
20
30
50
300
100 000
Laboratory return
Ward returns (n=10)
negative
Weak positive
Weak positive
positive
positive
Positive
Positive
Negative (100%)
Positive (90%) weak positive (10%)
Positive (90%) Negative (10%)
Positive (100%)
Positive (100%)
Positive (100%)
Positive (100%)
Any other details
The latest copy of this SOP and related documentation can be found in the POCT
section of the Southern trust laboratory inter/intranet site.
http://10.142.1.242/cahgt/Depts/Labs/webhb/Default.htm
References
Clinitest kit insert
Bayer Status operator’s manual
http://www.connectsac.com/pregnacy1.html
The retention and storage of pathological records and archives (3rd edition, 2005)
Guidance
http://www.rcpath.org/resources/pdf/g031_retentionstorageofrecords_oct06.PDF
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