LH iFlash

Immunoassay Analyzer

Calibrator 2, 1 bottle, 1.0 mL, LH in Tris buffer

CAL2
with protein stabilizers, 0.05% ProClin 300.
REF C86010 2×50 Tests
Calibrator 3, 1 bottle, 1.0 mL, LH in Tris buffer
CAL3
with protein stabilizers, 0.05% ProClin 300.
INTENDED USE
The iFlash-LH assay is a paramagnetic particle MATERIALS REQUIRED (BUT NOT PROVIDED)
chemiluminescent immunoassay (CLIA) for the REF C89999/C89959/C89949, iFlash Pre-Trigger
quantitative determination of luteinizing hormone (LH) in Solution: hydrogen peroxide solution.
human serum and plasma using the iFlash Immunoassay REF C89998/ C89958/ C89948, iFlash Trigger Solution:
Analyzer. sodium hydroxide solution.
SUMMARY AND EXPLANATION REF C89997, iFlash Wash Buffer: phosphate buffered
saline solution with 0.05% ProClin 300.
Luteinizing hormone (LH) is a glycoprotein hormone with
two subunits: α subunit and β subunit. Its α subunit is REF C80001, iFlash Wash Buffer (10×): phosphate
similar to α subunit of follicle stimulating hormone (FSH), buffered saline solution with 0.05% ProClin 300.
human chorionic gonadotropin (hCG) and REF C89996, reaction vessels.
thyroid-stimulating hormone (TSH). However, its β subunit Controls: Commercial controls could be used.
is different from other glycoproteins hormones with
specific biochemical characters. WARNINGS AND PRECAUTIONS
Abnormal LH level is correlated with increasing or IVD For in vitro diagnostic use
decreasing level of FSH, estrogen, progesterone and  No known test method can offer the complete
testosterone and many pathological conditions. assurance that products derived from human sources
Determination of the concentration of LH is essential for will not transmit infection. Therefore, all human
the prediction of ovulation, in the evaluation of infertility, sourced materials should be considered potentially
and the diagnosis of pituitary and gonadal disorders. It can infectious.
also be used in vitro fertilization.  Exercise the normal precautions required for handling
all laboratory reagents.
ASSAY PRINCIPLE
 Disposal of all waste material should be in accordance
The iFlash-LH assay is a sandwich immunoassay.
with local guidelines.
 Incubation: LH in the sample, anti-LH coated
 Wear gloves when handling specimens or reagents.
paramagnetic microparticles and anti-LH
acridinium-ester-labeled conjugate react to form a  Clean and disinfect all spills of specimens or reagents
sandwich complex. using a suitable disinfectant.
 Wash: The unbound materials are washed away from  iFlash Trigger solution contains sodium hydroxide
the solid phase in a magnetic field. (NaOH) and should be avoided contact with eyes.
 Trigger of signal: The Pre-Trigger and Trigger REAGENT HANDLING
Solutions are added to the reaction mixture. The
 The reagents may not be used after the stated
resulting chemiluminescent reaction is measured as
expiration date.
relative light units (RLUs).
 Avoid the formation of foam with all reagents.
 A direct relationship exists between the amount of LH
in the sample and the RLUs detected by the iFlash  The reagents in the pack and calibrators are ready for
optical system. use. Close the bottles of calibrator right after
calibration and store at 2–8°C.
 Results are determined via a calibration curve, which
is instrument-specifically generated by 3-point  Do not pool reagents within a reagent kit or between
calibration and a master curve provided via the reagent kits.
reagent QR code.  Prior to loading the iFlash-LH reagent pack on the
system for the first time, resuspend the microparticles
REAGENTS by inverting the reagent pack 30 times slightly.
Reagent kit, 100 tests, 2 packs, 50 tests/pack  For further information on reagent handling
Anti-LH coated microparticles, 3.5 mL/pack, precautions during system operation, refer to the
R1
0.05% ProClin 300. iFlash system operating instruction.
Anti-LH acridinium-ester-labeled conjugate; STORAGE AND STABILITY
R2
4.0 mL/pack; 0.05% ProClin 300.

Calibrator 1, 1 bottle, 1.0 mL, Tris buffer with Storage:

CAL1
protein stabilizers, 0.05% ProClin 300.  Store at 2–8°C in an upright position.

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LH iFlash
Immunoassay Analyzer

 The kit may be used immediately after removal from determination in addition to the sample container and
2-8°C storage. system dead volumes).
 Click RUN, the iFlash System performs all the
Stability:
functions automatically and calculates the results.
 Unopened at 2–8°C: up to the stated expiration date.
 LH in the sample concentration is lower than 360,000
 Opened at 2–8°C: 28 days. mIU/mL, there will be no HOOK effect.
 Store on-board: 28 days.
CALIBRATION
SPECIMEN COLLECTION AND PREPARATION  Traceability: This kit calibrator is traceable to the
 Serum or plasma (lithium heparin, sodium heparin Chinese Academy of Food and Drug test LH standard.
potassium EDTA, and sodium citrate) are the  Every iFlash-LH reagent kit has a QR code label
recommended samples. Other anticoagulants have containing the specific information for calibration of the
not been validated for use with the iFlash-LH assay. particular reagent lot.
 Ensure that serum specimens to form complete clot  To perform an iFlash-LH calibration, test CAL1, CAL2
prior to centrifugation. (No less than 1 hour.) and CAL3 in duplicate, and the predefined master
 Centrifuge the specimens. curve is adapted to the analyzer.
 Store specimens at room temperature (20 to 25°C) for  Once an iFlash-LH calibration is accepted and stored,
no longer than 8 hours. all subsequent samples may be tested without further
 Store specimens at 2-8°C for no longer than 3 days. calibration unless:
 If the testing will not be completed within 8 hours,  After 28 days when using the same reagent lot.
refrigerate the samples at 2 to 8°C.  A reagent kit with a new lot number is used.
 If the testing will not be completed within 3 days, or for  Controls are out of range.
shipment of samples, freeze at -20°C or colder.  Required by pertinent regulations.
 Frozen specimens must be mixed thoroughly after
thawing. MEASURING RANGE
 The samples may be frozen for maximum 1 time.  0.20 -250 mIU/mL
 Centrifuge specimens with a lipid layer on the top, and QUALITY CONTROL
transfer only the clarified specimen without the lipemic
Quality control materials should be run as single
material.
determinations at least once every 24 hours when the test
 Ensure that residual fibrin and cellular matter have is in use, once per reagent kit and after every calibration.
been removed prior to analysis. Include commercially available quality control materials
 Use with caution in handling patient specimens to that cover at least two levels of analyte. Follow
prevent cross-contamination. manufacturer’s instructions for reconstitution and storage.
 Do not use heat-inactivated samples. Each laboratory should establish mean values and
acceptable ranges to assure proper performance. Quality
 Ensure that the patient samples, calibrators and
control results that do not fall within acceptable ranges
controls are at ambient temperature (20–25°C) before
may indicate invalid test results.
measurement.
 Due to the possible evaporation, specimens and RESULT
calibrators on the analyzers should be measured
within 2 hours. Calculation:
The iFlash system automatically calculates the analyte
ASSAY PROCEDURE concentration of each sample. The results are given in
 Refer to the system operating instruction or the online mIU/mL.
help system for detailed information on preparing the
system. Expected Values:

 The test-specific parameters stored in barcode on the A study of iFlash-LH assay on samples from 725
reagent pack are read in. In case the barcode cannot apparently healthy persons of various age groups yielded
be read, enter the sequence numbers. the following result:

 Carry out calibration, if necessary. Females

 Place the calibrators CAL1, CAL2 and CAL3 in the
calibrator rack in the sample zone. Only keep Males Follic Ovulato
Luteal Meno
calibrators open during calibration. ular ry
phase pause
 Test application. phase phase
 Load samples (Use 30 μL of sample for each

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LH iFlash
Immunoassay Analyzer

Number 123 123 124 122 122 shown below:

Sample Mean (mIU/mL) SD %CV
Expected 1 11.27 0.38 3.36
1.1 2.1 20.0 1.2 10.0
values
-8.7 -11.2 -95.0 -11.2 -60.0 2 50.33 2.10 4.17
(mIU/mL)
The between run precision was determined by testing
It is recommended that each laboratory establish its own each sample in duplicate, two separate runs daily for 20
expected reference range for the specific population. days (n = 80), and calculating percent coefficient of
variation (%CV). The results of the study are shown
LIMITATIONS
below:
 The iFlash-LH assay is limited to the determination of
Sample Mean (mIU/mL) SD %CV
LH in human serum or plasma (lithium heparin, sodium
heparin, potassium EDTA, and sodium citrate). It has 1 10.91 0.48 4.40
not been validated for use with other types of plasma.
 The use of serum separator (gel) blood collection 2 50.52 2.14 4.24
tubes has been validated for use with this assay.
However, it is not possible to survey all manufacturers Analytical Sensitivity
or tube types. The detection limit representing the lowest measurable
 The upper limit of the measuring range of this assay is analyte level is 0.20 mIU/mL, which can be distinguished
250 mIU/mL. Over-range samples may be diluted with from zero. It is calculated as the value lying two standard
washing buffer (1:4) and re-tested to obtain an deviations above that of the lowest standard of the master
estimate of the actual concentration. curve (standard 1 + 2 SD, n = 20).
 If the results are inconsistent with clinical evidence,
Method Comparison
additional testing is suggested to confirm the result.
A comparison of the iFlash-LH assay (y) with a
 For diagnostic purposes, the results should be
commercially available LH assay (x) using clinical
interpreted in light of the total clinical presentation of
samples was performed, and the curve is fitted with Linear
the patient, including symptoms, clinical history results.
regression)
 Specimens from heparinized patients may be partially
y = 1.024x -2.127
coagulated and erroneous results could occur due to
the presence of fibrin. r = 0.9628
 The results from an alternative assays (i.e. EIA or RIA) Sample concentration: 0.40 – 265 ng/mL
may not be equivalent and cannot be used Number of samples measured: 88
interchangeably.
REFERENCES
 The assay is unaffected by icterus (bilirubin < 10
1. Burtis CA, Ashwood ER. Gonadotropins
mg/dL), hemolysis (Hb < 500 mg/dL), lipemia
(Intralipid < 1,800 mg/dL) and total serum protein (< 10 (follicle-stimulating hormone. Luteinizing hormone). In:
g/dL). Tietz NW, editor. Textbook of clinical chemistry. 2nd
ed. Philadelphia: WB Saunders, 1994. p.1679.
 No interference was observed from rheumatoid factors
2. Nickel KL. The gonads. In: Kaplan LA, Pesce AJ,
up to a concentration of 2,000 IU/mL.
editors. Clinical chemistry; theory, analysis, correlation.
 No interference was observed from anti-nuclear
3rd ed. St. Louis: CV Mosby-Year Book, Inc., 1996.
antibodies up to a concentration of 500 U/mL.
p.894.
 No interference was observed from HAMA up to a
3. Scott MG, Ladenson JH, Green ED, et al. Hormonal
concentration of 600 ng/mL.
evaluation of female infertility and reproductive
PERFORMANCE CHARACTERISTICS disorders. Clin Chem 1989; 35: 620-9.
Below are the representative performance data, and the 4. Butt WR, Blunt SM. The role of the laboratory in the
results obtained in individual laboratories may differ. investigation of infertility. Ann Clin Biochem 1988; 25:
601-9.
Precision 5. Reissman TH, Felberbaum R, Diedrich K, et al.
The precision of iFlash-LH was determined using LH Development and applications of luteinizing hormone-
reagents and controls. Two controls, consisting low, and releasing hormone antagonists in the treatment of
median concentration of LH were assayed. infertility: and overview. Human Rep 1995; 10 (8):
The within run precision was determined by testing each 1974―81.
sample in replicates of 10 (n = 10), and calculating percent
coefficient of variation (%CV). The results of the study are

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LH iFlash
Immunoassay Analyzer

SHENZHEN YHLO BIOTECH CO., LTD.

1st-4th Floor, No.5 Building, Lishan Industrial

Area, Xinghai Road, Nanshan District,
Shenzhen 518054, P.R. China

Wellkang Ltd (www.CE-marking.eu)

Suite B, 29 Harley St., London W1G 9QR, UK

ANNEX A:
Explanation of abbreviation

Abbreviation Explanation

Product No.

Calibrator

Reagent

Number of tests

Manufactured by

EU Representative

EC Declaration of Conformity

Caution

Instructions for use

In vitro diagnostic medical

device

Lot No.

Date of manufacture

Expiry date

Biohazard Symbol

Pictograms for Caution

Pictograms for Hazardous to the

aquatic environment

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