Product Manual

ManualsBrandsSekisui Diagnostics ManualsPregnancy Test HCGOsom® Ultra Hcg Combo Urine Test - 25/bx

STEP 1

For each test, open one OSOM hCG Serum/

Urine pouch, and label the OSOM device with

the patient ID.

STEP 2

Holding the dropper in a vertical position, add

3 drops of sample into the Sample Well (S)

STEP 3

Read the results at 3–5 minutes.

Do not interpret the results after 5 minutes.

Positive

Two pinkish-purple lines, one each at the Test Position

(T) and at the Control Position (C). Each of the

following indicates a positive test result.

Negative

Only one pinkish-purple line, at the Control Position (C).

Invalid

A distinctive colored line at the Control Position (C)

should always appear. The test is invalid if no Control

line forms.

Ultra hCG Combo Test

Rev. P-51560, 04/15

Summary of content (8 pages)

PAGE 1
STEP 3 Read the results at 3–5 minutes. Do not interpret the results after 5 minutes. STEP 2 Holding the dropper in a vertical position, add 3 drops of sample into the Sample Well (S) STEP 1 For each test, open one OSOM hCG Serum/ Urine pouch, and label the OSOM device with the patient ID. Negative Only one pinkish-purple line, at the Control Position (C). Positive Two pinkish-purple lines, one each at the Test Position (T) and at the Control Position (C).
PAGE 2
® Ultra hCG Combo Test CLIA Complexity: Waived for Urine Non-Waived for Serum THIS TEST IS FOR PROFESSIONAL USE IN PHYSICIANS’ OFFICES AND CLINICAL LABORATORIES. INTENDED USE OSOM Ultra hCG Combo Test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.
PAGE 3
• • inconsistent test results. Such specimens should be clarified by centrifugation prior to assaying. If refrigerated, bring specimens to room temperature (18–30°C) prior to testing. Frozen specimens must be completely thawed, thoroughly mixed, and brought to room temperature prior to testing by allowing the specimens to stand at room temperature for at least 30 minutes.
PAGE 4
Negative Only one pinkish-purple line, at the Control Position (C). NOTE: In the absence of hCG, or in the case that the hCG concentration is below the detection limit of the test, there will be no apparent line at the Test position. The control line at the Control Position should be clearly readable. Invalid A distinctive colored line at the Control Position (C) should always appear. The test is invalid if no Control line forms.
PAGE 5
tested before using a new lot, untrained operator or a new shipment of kit as good laboratory testing practice and that users follow federal, state, and local guidelines for quality control requirements. For information on how to obtain controls, contact Sekisui Diagnostics Technical Service: Tel 800-332-1042 (U.S. Customers only). EXPECTED VALUES OSOM Ultra hCG Combo Test is capable of detecting hCG levels of 25 mIU/mL (WHO 3rd International Standard).
PAGE 6
Sensitivity- Serum Assay Standard controls (calibrated to the WHO 3rd International Standard) ranging from 5 mIU/mL to 40 mIU/mL in serum tests were tested in 20 replicates. The results confirmed sensitivity of 25 mIU/mL. Specificity Thirty-six (36) urine specimens collected from menopausal women were studied. Specimens from menopausal women are known to interfere frequently with pregnancy tests due to cross-reactivity with other gonadotropin hormones.
PAGE 7
REFERENCES 1. Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and Wade, M.E. Serum Human Chorionic Gonadotropin Levels Throughout Normal Pregnancy. Am. J. Obstet. Gynecol. 1976; 126:678. 2. Krieg, A.F. Pregnancy Tests and Evaluation of Placental Function in: Clinical Diagnosis and Management by Laboratory Methods, 16th ed., Henry, J.B. (ed.) W.B. Saunders Co., Philadelphia, pp. 680, 1979. 3. Brody, S. and Carlstrom, G. Immunoasay of Human Chorionic Gonadotropin in Normal and Pathologic Pregnancy.
PAGE 8
SYMBOLS KEY Instructions For Use (Read) Item Number Store At Expiration Date CONT DEV Contents Test Device IFU Instructions For Use PIP Transfer Pipette 2 Do Not Reuse For In Vitro Diagnostic Use Lot Number Manufacturer MF Manufactured For